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    Skills Alliance is a fast growing, specialist life science recruitment firm with offices in London, New York, Seattle, Newport Beach and Zurich. Due to client demand and subsequent business growth, we are looking to hire ambitious, driven and self-motivated Principal Consultants to build on our current success and become future business leaders.

    We are open to consultants from any specialist sector, for example energy or finance who are now looking for a change in market and the opportunity to develop with a fast growing International business.

    We offer uncapped commission, good basic salaries, career development based on ability rather than tenure, individual and team incentives and a very entrepreneurial work atmosphere. The business offers a specialist, boutique feel but with the opportunity to develop your career quickly by working with a highly experienced and internationally recognised senior management team.

    As a new employee you will benefit from the following:

    • The ability to work with market leading consultants and work on and influence top tier executive search work
    • Travel across Europe and Internationally
    • Monthly, quarterly and bi-yearly incentives and holidays
    • Freedom to share and implement your own ideas

    Your primary duties will be focused on building up your specialist vertical market, becoming a subject matter expert and developing your brand and identity within Skills Alliance and the industry. On a day to day basis the core duties for this position will involve:

    • To drive growth and develop the specified vertical market for Skills Alliance on a Pan European basis.
    • You will act as a 360 consultant and as such will be responsible for both client and candidate development.
    • To achieve consistent and rising revenue generation within the specified vertical of the Life Sciences / Pharmaceutical sector.
    • The successful candidate will be expected to offer constructive, entrepreneurial and forward thinking ideas and concepts to assist in the development and growth of Skills Alliance as a leading Global Pharmaceutical Recruitment business.
    • To attend Industry specific conferences and symposia on behalf of Skills Alliance and represent the brand and organization. Build talent-pools of candidate resumes and establish yourself within a vertical market.
    • Screen resumes and qualify potential candidates about suitable job vacancies.
    • Develop leads for new business and conduct business development with new clients within the target vertical by agreeing working agreements and establishing terms of business with Life Sciences / Pharmaceutical companies.

    Additional requirements

    • Ideally you will have a minimum of a University degree
    • Strong communication skills and the ability to build relationships with a variety of customers.
    • At senior level, we would be looking at full 360 recruitment experience with an ability to demonstrate client and candidate acquisition.
    • An ability to listen, learn and apply new ideas quickly
    • Most importantly, we want to hear from people who always strive to be the best at anything they apply themselves to do.

     

    If you are interested in a confidential discussion, please do apply to this job advert with a CV and cover letter explaining the reasons for your interest in the position.

  • Market Access

    Highly competitive salary and benefits
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    Skills Alliance has partnered exclusively with a leading Diabetes company to hire a Head of Market Access DACH. The organisation is dedicated to developing technology that improves the lives of patients with diabetes.

    The Head of Market Access DACH is responsible for the design and delivery of the Market Access strategy to maximise access to their products in the region and prepare for a series of new launches. This will include building strong value dossiers, an optimised pricing strategy, educating key stakeholders, and influencing medical policy decisions.

    The location of the position is flexible within Germany.

    Requirements:

    • Degree in Health Economics, Medicine or another subject relating to Market Access
    • Experience in the Life Sciences industry (previous diabetes experience is an advantage but not essential)
    • Expert knowledge of the German reimbursement system, including government legislation, regulatory system and insurance system
    • Experience creating value dossiers and completing HTA submissions, leading or contributing to price negotiations, and working with Health Economists to produce cost-effectiveness and budget impact models
    • Knowledge of the Swiss and Austrian reimbursement system is an advantage but not essential
    • Ambitious and driven individual with excellent communication skills and a desire to work collaboratively with cross-functional colleagues
    • Fluent in German and English

    The salary and benefits are highly competitive and dependent on the level and quality of previous experience.

    For a full job description and client briefing, please call Oliver Drew on +44 (0) 203 862 9603 or email him to arrange a confidential discussion.

  • Regulatory

    £60 - £63 per hour
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    Skills Alliance are partnering with a very exciting Global Biopharmaceutical Company who are focusing on bringing a new drug through from the clinical trial to commercialisation across Europe.

    They need a strong Regulatory Affairs Manager who is able to support to the Intercontinental & Global Patient Solutions team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 5 day a week freelance position for 12 months initially to be based in London and an excellent rate on offer.

    Please attach your CV to your application to ease the process.

    Email: shakir.hossain (at) skillsalliance.com

  • Clinical Operations

    Excellent Salary and Package
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    An innovative, Swedish Biotechnology company in Southern Sweden, are now looking to grow their clinical team after starting their treatment on for immuno-oncology. This role opening is very time urgent so do not hesitate to apply.

    They specialise in early phase research they are currently amid revolutionary treatment of haematology and solid tumours. Because of this they require strong trial management experience within Oncology, ideally early phase experience (I and II). They would prefer experienced candidates in Pharma/Biotech but will consider CRO candidates too.

    They are looking for: (Senior) Clinical Project Manager

    (Senior) Clinical Project Manager – with at home flexibility, minimal travel.
    – Need to be open to being in the office 2-3 days a week, you will have the flexibility to work from home.
    – Project, study, or trial management experience.
    – Experience in Oncology, as well as managing Oncology based studies.
    – Oncology experience is essential.

    – Proficient in written and spoken English.

    This is a full time and permanent position.
    It is office based in Southern Sweden, with flexibility.

    They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Clinical Development

    £50000 - £70000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (Euston). They will offer a very competitive salary – circa £60-70K depending on experience + full benefits package.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team and will consider CRO or Pharma experience, this would be working on studies at the cutting edge of science. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    Excellent Salary and Package
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    An upcoming German owned Biotech company is now looking to grow their clinical team after starting new developments in Oncology treatment. This role opening is time urgent so do not hesitate to apply.

    They are a small biotech within Munich and are currently and are looking for an experienced Clinical Trial Associate to join the team and make a difference through their organised nature and their strong administrative ability. This is an opportunity to be a part of the process from the very beginning, a hands on role with a small and welcoming team.

    This is a permanent, full time role, so this means there may be a scope for progression within the firm. They are going through major development regarding bringing on a new electronic TMF system. Which is why they need an experienced clinical trial associate with a strong clinical background.

    Clinical Trial Associate/Assistant – office based

    – Must be willing to commit to into the office 5 days a week.

    – Have experience in eTMF management.

    – Experience in TMF.

    – Proficient in written and spoken English.

    This is a full time and permanent position.

    They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Medical affairs

    £65000 - £75000 per annum, car allowance + bonus
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    Senior Compliance Officer – Brand new role, brand new team

    I am currently working with a client of mine who are looking for an addition to their small compliance team. This is a brand-new team, and so you will be joining as part of a new role within the team and will play a pivotal role in championing compliance across the business.

    My client are specialists across various therapeutic areas and are building a compliance team that can promote the vision of compliance across the company.

    For this position, my client is looking for someone who has experience in a healthcare compliance role. You must have an excellent understanding of the ABPI and IPHA codes of practice. You will be working as part of the compliance team to ensure that these codes of practice are adhered to and you will be the point of contact for compliance in the company.

    Although this is a UK and Ireland role, this position will give you the opportunity to work closely with the EU affiliates as well as working closely with other functions within the company such as sales and marketing and regulatory affairs, as well as medical affairs.

    This is a great opportunity for anyone looking to take the next step in their career and is perhaps looking for a position in which they can take on a wealth of experience and be part of a growing team, with opportunities for growth in the future.

    For more information, please contact Chanel Hicken on 0207 220 6206 for a confidential discussion.

  • Quality

    Competitive + Benefits
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    An expanding Sterile manufacturing company are currently looking to appoint a Quality Director. Already possessing an impressive portfolio they intend to develop this further with their current pipeline making this position pivotal in being able to fulfil this strategy.

    You will be working alongside the Managing Director and be responsible for directing and implementing strategies across the business. You will also be responsible for ensuring compliance with regulatory requirements and managing the internal compliance programs associated with the entire product lifecycle. Experience with QMS management, internal and external audits including site inspection readiness by the FDA & MHRA are essential.

    The main responsibilities of this position will be:

    • Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non-Executives.

    • Oversee the internal GMP and quality system audit program for all products.

    • Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.

    • Facilitate the management review process with executive management.

    • Ensure the quality and compliance of all required regulatory notifications.

    • Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary.

    • Monitor the external FDA & MHRA regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.

    • Develop and sustain a high performing team of direct reports, with attention to development and succession planning.

    • As a member of the Executive Team, contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.

    • To grow and develop the business through the identification and progression of opportunities and by establishing strategic collaborations and interactions with third parties including public and private sector bodies.

    • To lead and manage the business, via a management team, to secure the delivery of high-quality products/services in an effective and timely fashion.

    • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness.

    • To report on the business and performance of Quality as required to the Board and others.

    • To take responsibility for all HR issues within the division.

    • To actively contribute to the development and achievement of translational and other programmes.

    • To take Executive responsibility for Health and Safety across the company.

    • To contribute to publications in national and international journals as appropriate.

    If this position looks to be well aligned to your skill set, apply now in order to discuss the opportunity further.

  • Quality

    £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Supervise the Microbiology Team and be responsible for all microbiological testing
    • Report results to the QA team
    • Manage the Environmental Monitoring program on site
    • Perform sampling and testing of water on site

    Requirements:

    • 3+ years of experience in a similar position
    • GMP, GLP knowledge/ understanding of Data Integrity
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Lavina Rose for more details on 02072206218.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Data Management

    £250 - £300 per day
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    Skills Alliance are recruiting on behalf of a global top-20 Medical Device manufacturer, who are seeking an experienced Data Analyst professionals, with a strong, proven track record in process improvement projects across a global environment. You will be working with teams located in South East Asia & Central America, so demonstrable experience working with integrated teams in these locations would be highly beneficial. This will be a 100% remote based role, however you will be required to hold a right to work in the UK.

    Job Purpose:

    • With the introduction and release of a client single product hierarchy, there is a requirement to hire a product support analysis to aid with the development and implementation of new process.
    • Working closely with the stakeholders, the project team and various global and local Subject Matter Experts to define requirements, support process enablement and produce/update documentation to the highest quality and standards. Collect and analysis of data to providing recommendations to the project team and the maintenance of change plans.

    Key Responsibilities:

    • Responsible for the maintenance of the Product Hierarchy source system.
    • Liaise with global Client markets on both strategic and non-strategic EPRs and support the introduction and embedment of new processes.
    • To ensure local NPI process are aligned with the SPH and that proactive steps are taken to continuously maintain and update the source system.
    • Assist with the refinement and deployment of new processes in order to ensure smooth transition.
    • Work with the project team to analyse reports and take steps to educate and develop process capability.
    • Liaise with key stokeholds and provide guidance on required changes.
    • Provide the core project team with weekly progress updates.
    • Ensure source system data is of high integrity.
    • Further development and improvement of associated policy and processes.
    • Develop and maintain training material.
    • Deliver training to global and local teams.

    Required Experience:

    • Minimum of 2 years experience with Process improvements within a large organisation.
    • Minimum of 2 years experiencing collating and interpreting data, and providing meaningful analysis.
    • Some experience of working with a high level of engagements within a global intergrated teams. Will be working with teams based in South East Asia & Central America.
    • Flexible working hours will be critical for this position.

    Desirable Experience:

    • P360 expericence
    • Some knowledge of Master Data desirable.
    • Some exposure to Lean Six Sigma.
    • Experience using Informatica desirable.
    • Certification as a BA and/or BI.
    • Exposure to Change Management techniques
  • Pre-Clinical

    £90000 - £110000 per annum, Bonus + shares
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    Director of pre-clinical role with cutting edge UK based Biotech, who are growing at present. Based in the South East of the UK.

    Evox are a relatively new exosome therapy focussed Biotech. They have unique technology to engineer and use exosomes for drug delivery – a very exciting and new area within advanced therapies so working at the cutting edge of science.

    They are recruiting for multiple Director roles in their pre-clinical team. They would be overseeing a group (around 7 initially, growing to 12, comprising of group leaders and scientists). They are looking for someone who has advanced therapies experience and someone PhD qualified, they also need candidates with strong leadership and line management experience.

    This is a permanent and full-time position. They are based in the South East and it would be an office-based role with flexibility. The salary would be able to offer is around £90-110K for Director + bonus + benefits. Shares/options would also be part of the package.

    This is a full-time and permanent position. It is office-based in the South East with flexibility. They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details on +44 207 220 6209 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
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    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Regulatory

    Competitive
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    Skills Alliance is currently partnered with the leading global pharmaceutical company based in the northern part of Switzerland. For this purpose, our client is looking for a Sr. Regulatory Manager Vaccines Europeto join their team on a 12 month long term Contract with a possibility of further extension.

    OBJECTIVES:
    • Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.
    • Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region
    • Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
    • Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
    • Responsible for regulatory oversight of assigned clinical trials conducted in the region.
    • Collaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.
    • Passion for quality in all areas of responsibility
    • Leads and directs the work of others as part of a matrixed organization.

    ACCOUNTABILITIES:
    • Close collaboration with the RAV Europe Region Head (and Local Operating Company (LOCs) RA as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
    • In cooperation with key stakeholders and RAV Europe Region Head (and LOC RA as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right-first-time.
    • Supports overall content and management of local/regional regulatory components and filings e.g. MAA, MA variations. Contributes to local/regional label development and submission.
    • Ensures compliance with both internal process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
    • Supports RAV Europe Region Head in the preparation of health authority interactions/meetings in the region as applicable for specified projects
    • Actively participate as member of teams within RAV supporting activities as assigned.
    • Manages specific projects as assigned.
    • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.

    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    • BS, advanced scientific degree preferred.
    • A minimum of 6 years of pharmaceutical industry experience, with a minimum of 4 years of regulatory experience.
    • European regulatory experience is essential. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval.
    • Vaccines and/or biologics experience is preferred.
    • Participation in Global regulatory filing is a plus.
    • Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
    • Pays strong attention to quality, and is working reliably and thoroughly.
    • Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.
    • Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
    • Team player

    LICENSES/CERTIFICATIONS:
    • None

    PHYSICAL DEMANDS:
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
    • Carrying, handling and reaching for objects.
    • Ability to sit or stand for long periods of time while traveling.

    TRAVEL REQUIREMENTS:
    • General willingness to travel to meetings, including overnight trips.
    • Requires 10% travel.

    If you are interested or you know someone who would be interested please apply directly here or feel free to contact Heena Verma via phone @ +41 44 798 2410.

    Thanks!

  • Quality

    £50000 - £65000 per annum
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    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Supervise the Microbiology Team and be responsible for all microbiological testing
    • Report results to the QA team
    • Manage the Environmental Monitoring program on site
    • Perform sampling and testing of water on site

    Requirements:

    • 3+ years of experience in a similar position
    • GMP, GLP knowledge/ understanding of Data Integrity
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Lavina Rose for more details on 02072206218.

  • Quality

    £25000 - £30000 per annum
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    Senior QA Officer

    I am currently exclusively partnering with a very exciting pharmaceutical company who are currently looking for a Senior QA Officer to join their growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in developing and managing quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, offering excellent long-term prospects.

    Responsibilities:

    • To prepare and update SOPs
    • To make sure relevant personnel is trained on new SOPs
    • To prepare and review product quality reviews
    • To prepare monthly summary

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
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    Share

    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Quality

    £30000 - £40000 per annum
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    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    Share

    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    €90000 - €120000 per annum
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    Share

    Skills Alliance are working with a global, reputable pharmaceutical organisation who are seeking an experienced R&D Procurement Category Lead with a strong track record in medical affairs. Based in Berlin, this will be an excellent opportunity for someone to grow within a highly-ambitious, strategic procurement function.

    Purpose & Responsibilities:

    • Work within the R&D Procurement team to lead the creation and ensure the implementation of procurement category strategies for key global Medical Affairs categories including late phase clinical studies, real world data, and pharmacovigilance that add significant value for the business (e.g. external innovations, savings, payment terms, increased compliance/sustainability and reduced risk)
    • Keep up to date on category market intelligence and supply market trends to gain competitive market advantage and to make better business decisions (e.g. new potential suppliers), to understand how the innovation potential can be leveraged successfully within (sub-)category
    • Translate results of category strategies, initiatives and projects into sourcing approaches and operational instructions and jointly agree them with external partners
    • Ensure and be accountable that processes and system content reflect category strategy
    • Establish effective, trustful and personal relationships with key business stakeholders to understand business requirements, set joint targets and be the contact point for all procurement related topics for the business stakeholder community
    • Define what value procurement can add for the business stakeholder community and propose strategic initiatives that deliver against the defined value


    Key Requirements:

    • Long-term professional procurement experience
    • Solid category expertise/understanding of R&D/Medical Affairs area
    • Strong stakeholder engagement skills combined with strong influencing skills
    • Ability to work in a global and virtual working environment and to lead virtual teams
    • Good knowledge and expertise in procurement and procurement processes and methodologies
    • Ability to articulate credible pictures and visions of possibilities that will create sustainable value
    • High proficiency level in English, both written and spoken


    Required Education:

    • Master or equivalent degree in science or business management (PhD preferred)
  • Clinical Operations

    Excellent Salary and Package
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    I have partnered with an upcoming, Swedish Biopharmaceutical company located in Stockholm. This is a great opportunity to join quite a niche Biopharma from the very beginning.

    They are now looking to grow their clinical team after successfully completing their early phase studies where they have had extremely positive results. This means they will need a Senior Project Manager / Project Lead / Director of Clin Ops that can lead their team on a global scale for their Phase II trials which may be outsourced to CRO’s.


    They are looking for: Senior Clinical Project Manager / Project Lead / Clin Ops Director – with remote working, minimal travel.

    Key Requirements:

    – Proficient in written and spoken English.

    – Ability to work independently, but also lead a global and regional team for clinical trials.

    – They need someone based in Stockholm or able to work remotely and go the office every few weeks.

    – Strong clinical trial/project management experience.

    Preferred:

    – Experience of overseeing and managing outsourced studies in Pharma/Biotech.

    – Happy to do hands on trial management.

    – Experience across phases I, II and III.

    This is a full time and permanent position.
    It is a remote working role, with occasional travel to their Stockholm office.

    They will offer an excellent salary and package, which can be discussed and negotiated if you meet their requirements.

    Skills Alliance are the preferred supplier for this role. Please contact Brie Welch for more details on +44 (0)204 513 0648 or click APPLY NOW.

  • Quality

    £50000 - £65000 per annum
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    Share

    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • HR and talent acquisition

    Rate on application
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    A global biopharmaceutical company are recruiting for a HR Shared Services Advisor based in Uxbridge. This position will be responsible for providing HR support across the European region. They are looking for a contractor who will support and serve as a first point of contact for employees, managers and HR Business Partners, providing high quality HR advice and guidance with a focus on excellent customer service on a wide range of HR activities and processes.

    Key objectives

    • Utilise HRSM technology to triage, track and manage incoming enquiries and cases
    • Perform data entry across a range of HR systems
    • Create and maintain SOPs
    • Contribute to the ongoing development of the HR Shared Services FAQ library
    • Responsible for creating new starter offer documentation and all HR associated onboarding activities
    • Manage the administration of employee recognition programmes
    • Responsible for responding to external HR queries including reference requests
    • Support the preparation of monthly payroll and follow up on payroll queries
    • Manage core HR processes including on-boarding, off-boarding, absence management, benefits administration, and employee transfers
    • Manage employee files and related documentation in HR system
    • Always ensure compliance with appropriate data protection legislation


    Essential skills and experience

    • Must have experience working within an HR Shared Services environment
    • Must have an interest and understanding of general HR policies and procedures
    • Will have a strong customer service orientation while maintaining a high level of integrity and confidentiality
    • Must possess solid verbal, written, interpersonal and telephone communication skills
    • Must be able to identify critical situations and take action to escalate where necessary
    • Must demonstrate the ability to work in a team
    • Must be able to multitask yet remain detailed-oriented with sound time management skills
    • Must possess strong Microsoft PowerPoint, Excel, Word, and Outlook skills
    • Must be able to perform role under minimal supervision
    • Experience with Workday, Service Now or similar HR systems is desirable

    This role is a 6-month contract role on an hourly rate of £16 p/hr.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • HR and talent acquisition

    Rate on application
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    A global pharmaceutical company are recruiting for a Project Assistant based in South East England, Surrey. This is an opportunity to join a reputable pharmaceutical company that are undergoing significant changes with a large underdoing Global Transformation programme.

    Objectives: Support the Coordinator in the Team Management activities of the ATL Team and act as the shadow ATL (Back Up) for one of the ATLs who has been assigned the Menassa, Israeli, Dutch, Swiss and Austrian affiliates.

    Deliverables:
    • Coordinate, Update and Monitor Activity Tracker
    • Coordinate/Publish Monthly ATL/FD Reporting and Monitoring List
    • Coordinate Weekly ATL call and daily ATL PMO call

    Experience:
    • Experienced in working across PMO support projects
    • Willing to take initiative and are confident in their abilities
    • Strong attitude to work
    • Strong use of Microsoft Office Excel

    This is a 12 month contract offering a daily rate of £194 a day.

    Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

  • Pre-Clinical

    £90000 - £110000 per annum, Bonus + shares
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    Director of pre-clinical role with cutting edge UK based Biotech, who are growing at present. Based in the South East of the UK.

    Evox are a relatively new exosome therapy focussed Biotech. They have unique technology to engineer and use exosomes for drug delivery – a very exciting and new area within advanced therapies so working at the cutting edge of science.

    They are recruiting for multiple Director roles in their pre-clinical team. They would be overseeing a group (around 7 initially, growing to 12, comprising of group leaders and scientists). They are looking for someone who has advanced therapies experience and someone PhD qualified, they also need candidates with strong leadership and line management experience.

    This is a permanent and full-time position. They are based in the South East and it would be an office-based role with flexibility. The salary would be able to offer is around £90-110K for Director + bonus + benefits. Shares/options would also be part of the package.

    This is a full-time and permanent position. It is office-based in the South East with flexibility. They will offer an excellent salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details on +44 207 220 6209 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Manufacturing

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for a Continuous Improvement Engineer to join our client’s manufacturing site on a permanent basis.

    Purpose
    • Lead or facilitate the resolution of critical issues (Problem Solvings)
    • Lead and support cross-departmental project teams to implement strategic OE projects, producing significant and measurable improvements and tangible financial results for the business.
    • Build Continuous Improvement (CI) capabilities within the organization training and coaching of Blue Belts, Green belts, and Black Belts.
    • Deliver Operational Excellence (OE) related training programs (5S, Blue Belt, or Green Belt trainings).
    • Continue to develop your OE Skills beyond your Black Belt competencies.
    • Deploy the CI Masterplan (Tiered accountability, 5S, Standard work, Visual Management, VSM, Training) • Continuously look for opportunities of improvement that will make the difference.
    • Continuously increase and diversify your OE, process, and business knowledge and understanding.

    Profile:
    • Education: Master degree in Engineering or in Science.
    • Lean and/or 6 Sigma certification is an asset.
    • Eager to develop his/her OE skills
    • Experienced in the biotechnology / pharmaceutical industry is required
    • Superior interpersonal and coaching skills.
    • Demonstrated ability to lead and motivate teams to achieve business goals.
    • Strong negotiation and consultation skills.
    • Excellent communication, presentation and facilitation skills.
    • Customer oriented, shopfloor oriented, data driven, pragmatic, passion for Continuous Improvement, result driven.
    • Advanced PC skills such as MS Office and Minitab.
    • Fluent in French and English (spoken and written).
    • Previous experience with Lean Transformations, Lean Assessment etc… is required

    If you’re interested in this position or if you would like to receive more information regarding this role, please apply or get in touch with Khephren Mongongu +41 43 508 29 16

  • Manufacturing

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for an Engineering Systems Specialist to join our client’s manufacturing site on a permanent basis.

    Purpose:

    The Engineering System Specialist is integrated in the Engineering Systems team. The scope of this position is to:
    •Create and improve the templates of engineering documentation including validation documentation
    •Create and improve engineering guidance to standardize the flow of the documentation and the validation requirements
    •Coordinate and Improve the structure engineering documentation repertory.
    •Coach partners of the engineering team to improve their documentation aspect
    •Write/Review project documentation drafted by engineers before the official validation review
    •Support engineering team for new projects according to GMP and Best Engineering Practices requirements.

    Scope of the function:

    •Filling and Packing Engineering and automation.
    •Purification / Utilities Engineering and automation.
    •HVAC and Facilities Engineering and automation.

    Major Accountabilities:

    •The incumbent is a validation expert supporting mechanical and automation engineering projects documentations (URS, Functional& design specifications, commissioning activities…)
    •Create and improve templates & guidance for Site Engineering activities (tenders, validation packages, …)
    •Support the redaction, coach engineers and review of documentations before Validation Agreement.
    •Recommend efficient improvement to qualify equipment and systems.
    •Coordinate engineering documentation activities to support the projects
    •Improve the department documentation structure.
    •Periodic review of Engineering procedures and forms to ensure alignment with local/divisional procedures
    •Assure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirements
    •Support site activities as a technical professional to facilitate investigations

    Technical/Functional (Line) Expertise:

    He or She is able to understand all technical installations, equipment and systems used on the site.
    He or She is comfortable with the main requirement of validation for a new system or equipment.
    He or She is comfortable with technical documentation, engineering aspects, protocols and quality documentation to support all activities on site.
    He or She is perfectly aware of current validation divisional procedure.

    Leadership:

    He or She is also able to be factual to report problematics to management.
    He or She is able to analyze the current process and identify the improvements to do to simplify and standardize.

    Decision-making and Autonomy:

    He or She is able to report his or her final evaluation of technical choices inside projects core team.
    He or She will present this final evaluation to a final review for coaching by the manager or the senior engineer before presenting the final statement for agreement at the superior management level.

    Interaction:

    He or She is a collaborative and proactive member inside a team.
    He or She is sensitive and highly consider humans problematics to interact with other departments with demonstrated communication skills.

    Innovation:

    Leads benchmark and innovative ideas, propose innovation long term plan.

    Complexity:

    He or She have to take as a main priority EHS aspects inside all interventions on line.
    He or She is aware of the complexity of products manufactured, the complexity of aseptic aspects.
    He or She is also able to understand humans challenge complexity, to be able to respect any interlocutors by applying ethics code.

    Education / Experience Required:

    •Master’s degree in Biologics, Validation, Mechanics, Automation, Electrics: (Or bachelor’s degree with additional experience)
    •Comfortable with the technology evolution for automation systems.
    •5 years as a Validation Engineer with efficient technical skills.
    •Core Competencies / Skills / Leadership Behaviors:
    •Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
    •Good communication, leadership and organizational skills
    •Has the ability to prioritize multiple tasks and work on multiple projects simultaneously
    •Client oriented, rigorous, synthetic and analytic thinking
    •Good written and verbal skills in French and English.
    •Must be sensitive to Data Integrity aspects.
    •Must be proficient with standard office software (Word, Excel and PowerPoint)

    If you are interested in or wish to know more about this position, please apply or get in touch with Khephren Mongongu +41 43 508 29 16.

  • Validation

    Competitive
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    Skills Alliance is currently partnered with a multinational biotechnology company, leader in the fields of immunology and hematology. On behalf of our client, we’re currently recruiting for a CSV Engineer to join our client’s manufacturing site on a permanent basis.

    Responsibilities

    The Validation Engineer II performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    1) Prepare and implement the validation documentation required to assure the proper development of a project.

    2) Act as a validation representative for projects, with support of his/her Validation Supervisor: Define and implement all validation activities related to the project. Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor.

    Provide validation expertise for the development of the project. Conduct the risk assessment related to the project.

    Review the URS, FS, DS and DR. Prepare the DQ. Review the commissioning protocols and reports to ensure leveraging into qualification.

    Prepare the IQ, OQ & PQ protocols. Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)

    Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the Validation Supervisor.

    3) Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

    4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

    6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.

    7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfilmentand EHS.

    Requirements

    Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline

    Minimum 2 years of experience in Validation/Quality systems Skills: Project management experience

    Excellent communication skills, fluent in French and good knowledge of English (written and spoken)

    Familiar with Quality Management and GxP Regulations. Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP. Knowledge of the manufacturing processes.

    Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Sound industry knowledge, project proficiency, and autonomy expected.

  • Project Management

    Competitive
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    The Project Manager – System Owner is in charge of managing a Package of equipment/systems from Design to Hand-Over and the team members dedicated to this package.

    She/He performs the Engineering tasks necessary for the proper functioning of the equipment/systems she/he is in charge of.

    Function and Responsibilities:
    You will be in charge of the Design, Commissioning, Qualification (if required) and Hand-Over for the designated package of equipment/systems according to our client’s scope agreement.

    Your main tasks will be:
    • To deliver and be the owner for the technical documentation linked to your equipment/systems (ex. URS, PFD, P&ID, etc…). You are responsible for their inputs, updates, availabilities and changes.
    • To make the financial follow-up for your designated package according to the scope of agreement.
    • To schedule all activities for your designated package according to the scope of agreement.
    • To be the main person of contact with the suppliers, coordinate the equipment’s activities availabilities from FAT/SAT until hand-over to the final users.
    • To be accountable for all activities happening on the field according to information discussed during technical meetings.
    • To make sure that all information is given in order to update the Overview Planning.
    • To ensure that all technical documentation is completed on time.
    • To coordinate C&Q activities with suppliers and Commissioning /Qualification Engineers.
    • To anticipate all activities (reception to hand-over) for your package according to the scope of agreement.
    • To be accountable to deliver documentation and activities follow up to your Quality partner in order to maintain KPI’s
    • To work as C and Q team member’s supervisor including mission follow up, holidays and day off management, workload supervision, planning supervision and training follow up for commissioning and qualification activities
    • To insure the change management according to the Change control system in place.

    Qualifications:
    • 5 to 7 years’ experience in the Biotech/Pharmaceutical manufacturing Industry
    • Engineering educational background preferably in Chemistry, Bioprocessing or technical engineering
    • Good organization and communication skills
    • Good knowledge of Biotech/Pharma Utilities systems and/or Biotech equipment and experience in automation systems
    • Good knowledge of risk assessment and control
    • Good knowledge of Construction & Design is a plus
    • Fluent in English and French
    • Travelling may be required
    • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP practices

    If you would like to know more about this position, please apply or get in touch with Khephren Mongongu +41 43 508 29 16.

  • Quality

    Rémunération Competitive
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    Skills Alliance recrute pour le compte d’une multinationale biopharmaceutique active dans le domaine de l’hématologie. Pour le site de production de notre client basé en Suisse Romande, nous sommes à la recherche d’un/d’une Chargé(e) de Qualité Opérationnelle (CDI).

    Votre mission

    Dans cette fonction, vous serez responsable de l’Assurance Qualité dans le cadre des activités tout au long des processus de production et de libération. L’expert en Assurance Qualité est le représentant Assurance Qualité pour les activités de routine BPF (Bonnes Pratiques de Fabrication) et les projets de notre client. Il/elle assurera la qualité des informations dans les systèmes et la documentation en ce qui concerne les directives, la conformité et les exigences réglementaires actuelles. La participation aux audits BPF fera partie des activités. L’expert en Assurance Qualité fera la promotion et sera impliqué dans l’amélioration continue.

    Responsabilités principales

    • Participer aux activités quotidiennes liées à la revue des dossiers de lot et des données associées pour la libération des lots en zone aseptique
    • Participer à la revue et évaluation des demandes de changement (”change control”) selon les procédures, méthodes, systèmes qualité et des dossiers règlementaires applicables pour répondre aux exigences du siège social, divisionnelles et règlementaires
    • Fournir le support QA aux activités de maintenance et des installations
    • Maintenir le ”mapping” organisé des variants de procédés (les codes produits)
    • Apporter du support quant à la résolution des problèmes/des causes à l’origine des déviations et CAPA
    • Exécuter les audits GMP internes en zone de production
    • Être un leader dans l’implémentation des projets du site en accord avec les exigences réglementaires et le département Qualité

    Profil recherché

    • Diplôme en Ingénierie, Biotechnologie, Pharmacie ou « Quality Management » appliqué aux procédés industriels ou expérience équivalente dans des sociétés pharmaceutiques et /ou biotechnologiques.
    • 4+ années d’expérience en Assurance Qualité ou en Contrôle Qualité
    • Connaissance des réglementations FDA, EMA, ICH, Pharmacopées et des normes système Qualité.
    • Connaissance des audits et inspections selon les normes règlementaires / qualité.
    • Expérience avec la disposition de produit.
    • Maitrise du français et niveau B2 en langue anglaise

    Pour recevoir plus d’informations sur cette offre, veuillez postuler ou contacter Khephren Mongongu au +41 (0) 43 508 29 16.

  • Quality

    £25000 - £30000 per annum
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    Senior QA Officer

    I am currently exclusively partnering with a very exciting pharmaceutical company who are currently looking for a Senior QA Officer to join their growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in developing and managing quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, offering excellent long-term prospects.

    Responsibilities:

    • To prepare and update SOPs
    • To make sure relevant personnel is trained on new SOPs
    • To prepare and review product quality reviews
    • To prepare monthly summary

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Medical affairs

    £65000 - £75000 per annum, car allowance + bonus
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    Senior Compliance Officer – Brand new role, brand new team

    I am currently working with a client of mine who are looking for an addition to their small compliance team. This is a brand-new team, and so you will be joining as part of a new role within the team and will play a pivotal role in championing compliance across the business.

    My client are specialists across various therapeutic areas and are building a compliance team that can promote the vision of compliance across the company.

    For this position, my client is looking for someone who has experience in a healthcare compliance role. You must have an excellent understanding of the ABPI and IPHA codes of practice. You will be working as part of the compliance team to ensure that these codes of practice are adhered to and you will be the point of contact for compliance in the company.

    Although this is a UK and Ireland role, this position will give you the opportunity to work closely with the EU affiliates as well as working closely with other functions within the company such as sales and marketing and regulatory affairs, as well as medical affairs.

    This is a great opportunity for anyone looking to take the next step in their career and is perhaps looking for a position in which they can take on a wealth of experience and be part of a growing team, with opportunities for growth in the future.

    For more information, please contact Chanel Hicken on 0207 220 6206 for a confidential discussion.

  • Regulatory

    Competitive + Benefits
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    Skills Alliance are currently partnering with a growing SME Biotechnology company with a focus on Research & Development of new Oncology drugs to combat forms of cancer with unmet needs in the marketplace.

    With successful commercialised products already on the market and promising results from their current clinical trials in relation to some of their key assets they are looking to appoint a Regulatory Affairs, Snr Manager to join their growing Regulatory Affairs team.

    This position is focused on assisting with CTA submissions but will also have cross functional elements allowing the appointed individual the potential to get involved with other regulatory functions such as MAAs and CMC.

    The main responsibilities held by the post holder will be:

    • Responsible for the preparation of clinical trial application regulatory submissions in compliance with global requirements. These will include EU documents such as initial CTAs and their accompanying IMPD, as well study/IMPD amendments, global documents such as IB updates and US documents such as IND safety report submissions.
    • Review and approve CTA related regulatory submissions, and support compliance check of regulatory approvals being in place prior to study site initiations and investigational product being provided.
    • Define and implement submission plans in conjunction with regulatory PT lead, clinical trial sub-team members, and participate in sub-team meetings to provide regulatory expertise and status updates.
    • Represent RA at clinical trial sub team meetings, identify needs and issues to the cross functional team.
    • Liaise with CRO regulatory contact, managing information/document needs and exchanges, agree upon submission strategy, ensuring the CRO is clear upon company deadline expectations.
    • Utilise CRO regulatory contacts to seek regulatory intelligence that will be beneficial to sub team discussions and strategy, maintaining regulatory relationships with counterparts.
    • Contribute to quality management, implementation of best practices and SOPS for CTA related activities.
    • Work with cross-functional team members to resolve issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution.
    • As a member of the global regulatory affairs team, contribute to process improvements, and inspection readiness amongst the department.
    • Maintain up to date knowledge of CTA related regulatory requirements and communicate in a timely manner any updates that may impact into the development programmes.
    • Develop and maintain CT regulatory intelligence data particularly related to oncology products.
    • Plan & schedule own activities as well as those of the RA Clinical Trial group members.
    • Support non-CT related RA project work as requested.

    The ideal candidate profile will hold an MSc or PhD in a Life Sciences degree and 6 years relevant industry experience within a Pharmaceutical, Biotechnology or CRO environment.

    As a growing organisation, they are always keen to offer incoming employees the scope to evolve and develop and will offer the opportunity to work cross functionally to support continual personal development.

    The package on offer is very competitive in relation to the market and the client is also flexible on home working.

    If this position looks to be of interest, apply now to discuss further.

  • Quality

    £36000 - £46000 per annum
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    QA Team Leader

    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a QA Team Leader position.

    You would be part of a well-established and well-known Pharma organisation, where you will get the chance to supervise and manage an entire quality team. As the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Work closely with the Quality Systems department
    • Support self-inspections/internal audits and customers’ audits
    • Generate PPQR data in readiness for assessment and approval
    • Ensure staff are always trained

    Requirements:

    • Minimum 3 years of relevant experience
    • Previous managerial experience
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Team Leader position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • Quality

    £50000 - £65000 per annum
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    PV Audit Manager

    You would be joining a fully integrated pharmaceutical company with a very strong portfolio, working across over 150 countries across the globe. The role requires an experienced PV Audit Manager with a strong background in Pharmacovigilance to provide QA leadership and oversight for PV audit activities.

    Responsibilities:

    • Manage QA PV Audits
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Process audits and affiliates audits, focusing on EU markets
    • Training of the EUPV affiliates for inspection readiness

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Vast experience within PV Audits
    • Vast Pharmacovigilance experience
    • Excellent verbal and communication skills

    This is a permanent position offering a competitive salary which can be discussed on the application.
    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £90000 - £100000 per annum
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    Head of Quality Assurance

    I am currently partnering with a leading global contract service company who are currently looking to appoint a senior level person for a Head of Quality within their growing site based in Ireland.

    This is a rare opportunity for an experienced Head of Quality with an extensive background in Good Manufacturing Practice to develop the quality function and work at a strategic level alongside the Director of Regulatory Affairs, while ensuring the overall maintenance of GXP standards. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To ensure batch reviews are completed and released in a timely manner
    • To ensure all QA staff are trained
    • To ensure all QC testing is carried out
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To host Regulatory Inspections and Customer Audits


    Requirements:

    • Minimum 6 years management experience
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Ability to lead organisational change
    • Ability to establish effective working relationships
    • Excellent leadership and communication skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Regulatory

    £40 - £45 per hour
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    Skills Alliance are partnering with a very exciting Biopharmaceutical Company who are focusing on bringing their licensed products in the US across to the LATAM and MENA regions. They need a strong Senior Regulatory Affairs Associate who is able to support to the cross functional team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 3 day a week contracting position for 12 months initially to be based in Oxford and an excellent rate on offer.

    Please Contact: shakir.hossain (at) skillsalliance.com

    For your ease please attached your CV to the application.

  • Quality

    £35000 - £45000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Pharmacovigilance

    £50000 - £60000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    PV Audit Manager

    Permanent Role

    You would be joining a company with strong EU presence and an impressive portfolio of strong devices on the pipeline. The role requires an experienced manager with a background in Pharmacovigilance to provide QA leadership and oversight for PV and device vigilance audit activities. This individual will also liaise with other directors, board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Plan and conduct and close out PV audits of processes, affiliates and third parties
    • Ensure continual compliance with policies, procedures, and PV regulations
    • Performing audits in line with PV and DV requirements
    • Proactively manage remediation actions to ensure activities are brought into compliance

    Requirements:

    • A scientific degree and relevant experience of Pharmacovigilance
    • Experience supporting partner audits and competent authority PV inspections
    • Excellent verbal and communication skills
    • Able to make data driven recommendation/decisions and take appropriate action

    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Clinical Development

    £70000 - £90000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Quality

    Competitive + Benefits
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    An expanding Sterile manufacturing company are currently looking to appoint a Quality Director. Already possessing an impressive portfolio they intend to develop this further with their current pipeline making this position pivotal in being able to fulfil this strategy.

    You will be working alongside the Managing Director and be responsible for directing and implementing strategies across the business. You will also be responsible for ensuring compliance with regulatory requirements and managing the internal compliance programs associated with the entire product lifecycle. Experience with QMS management, internal and external audits including site inspection readiness by the FDA & MHRA are essential.

    The main responsibilities of this position will be:

    • Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non-Executives.

    • Oversee the internal GMP and quality system audit program for all products.

    • Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.

    • Facilitate the management review process with executive management.

    • Ensure the quality and compliance of all required regulatory notifications.

    • Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary.

    • Monitor the external FDA & MHRA regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.

    • Develop and sustain a high performing team of direct reports, with attention to development and succession planning.

    • As a member of the Executive Team, contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.

    • To grow and develop the business through the identification and progression of opportunities and by establishing strategic collaborations and interactions with third parties including public and private sector bodies.

    • To lead and manage the business, via a management team, to secure the delivery of high-quality products/services in an effective and timely fashion.

    • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness.

    • To report on the business and performance of Quality as required to the Board and others.

    • To take responsibility for all HR issues within the division.

    • To actively contribute to the development and achievement of translational and other programmes.

    • To take Executive responsibility for Health and Safety across the company.

    • To contribute to publications in national and international journals as appropriate.

    If this position looks to be well aligned to your skill set, apply now in order to discuss the opportunity further.

  • Clinical Development

    £70000 - £90000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative Biotech.

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    The company has an exciting pipeline in both early and late phase research, they work in areas of unmet need and are progressing quickly to commericalisation. They work in a cutting edge and very exciting space in research.

    The Director, Project Management is a new role and will facilitate the successful delivery of several R&D programs associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation and strong CMC and manufacturing experience. Cross-functional PM experience is required and ideally line management experience.

    This is a full-time and permanent position which can be pre-dominantly home-based, going into the office a few days per week. There would be some travel to the R&D and Manufacturing sites. They will offer a very competitive salary – circa £70-90K depending on experience + full benefits package.

    Skills Alliance are the preferred partner for this role so please get in touch for more details, contact Mark Anderson on 0207 220 6209.

  • Quality

    £35000 - £40000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Finance

    £450 - £500 per day
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    Share

    Skills Alliance are partnered with a leading, global pharmaceutical organisation. As part of a multinational process transformation programme affecting various corporate service functions such as finance, procurement, supply chain and HR. As part of this programme, they are now seeking an experienced Trading Manager on an inital 6 month contract.

    This will be remote role, however may revert to office-based in Surrey and require international travel on occasion.

    Role Purpose:

    This position sits within the organisations trading entity, responsible for overseeing and liaising with Financial Accounting, Management Accounting, Compliance (Financial and Other), logistics, financial systems and process duties for the activities around the sale of product.

    The department is core legal entity within an EMEA Group and the results have a fundamental impact on the company strategy and group P&L, through the appropriate use of Transfer pricing, Marketing Right ownership and Marketing activities.


    Responsibilities:

    • Conduct financial/management accounting, JSOX compliance, logistics, and process duties for activities around the sale of products to EMEA affiliates and 3rd party distributors.
    • Provide commercial oversight to ensure appropriate governance and that transactions flow in accordance with API’s Tax & Transfer Pricing strategy and with EU tax legislation.
    • Work collaboratively across functions (including Other Group Trading & IP Holder Companies, API Finance, API Tax, European Tax, EUTD, Commercial Finance, EMEA Business Services).
    • Operate as an effective Finance Business Partner to internal and external stakeholders, collaborating to make effective decisions, and adding business value where possible.
    • Deliver timely and accurate financial reporting both internally and externally.
    • Apply initiative and commercial judgement to resolve problems, making timely decisions to support time sensitive commercial goods and services movement.
    • Work collaboratively as a member of the Finance team, contributing to overall performance through value add activities.
    • Interact with process owners and oversee transactional activities as executed by Finance teams.
    • Influence trading strategy across various trading entities and affiliates.
    • Provide support to decision-making around trading strategy and provide insight through partnering with other entities and affiliates.

    Required Experience:

    • Pharma sector experience with strong customer focus; in multi-disciplinary, matrix and cross-cultural settings.
    • Track-record of leading planning process with excellent organisational, collaboration and people management skills.
    • Demonstrable sustained finance experience within Finance functions
    • Proven compliance expertise; understanding and complying with industry laws and relevant regulations.
    • Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
    • Demonstrable examples of ability to develop, coach and enable high performance teams and proactively promote best practice and knowledge sharing.
    • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
    • Sound commercial awareness and ability to contribute to the success and development of the finance function and business in general
    • Audit experience preferable
    • Degree qualified, with post-grad accounting qualifications (ACA, ACCA)

    Plus demonstrable experience/exposure to a majority of the following areas:

    • Inventory knowledge – accounting/transactional knowledge/best practice
    • Financial Modelling & Analysis
    • Preparation of Management Reports
    • Preparation of Budgets & Forecasts
    • Variance Analysis including understanding of cost drivers, volume & pricing
    • Month End Close Process
    • UK GAAP, IFRS and group accounting experience
    • Internal Controls & process compliance work
    • Hands on use of Accounting & Reporting tools such as SAP, HFM
    • Liaison with auditors & professional advisors
    • Must have experience of working across multiple sites and localities
  • Clinical Development

    £60000 - £80000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston) with some flexibility. The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Share

    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Share

    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £65000 - £75000 per annum, Bonus + benefits
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    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
    Apply

    Job
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Regulatory

    Competitive + Benefits
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    Share

    Skills Alliance are currently partnering with a growing SME Biotechnology company with a focus on Research & Development of new Oncology drugs to combat forms of cancer with unmet needs in the marketplace.

    With successful commercialised products already on the market and promising results from their current clinical trials in relation to some of their key assets they are looking to appoint a Regulatory Affairs, Snr Manager to join their growing Regulatory Affairs team.

    This position is focused on assisting with CTA submissions but will also have cross functional elements allowing the appointed individual the potential to get involved with other regulatory functions such as MAAs and CMC.

    The main responsibilities held by the post holder will be:

    • Responsible for the preparation of clinical trial application regulatory submissions in compliance with global requirements. These will include EU documents such as initial CTAs and their accompanying IMPD, as well study/IMPD amendments, global documents such as IB updates and US documents such as IND safety report submissions.
    • Review and approve CTA related regulatory submissions, and support compliance check of regulatory approvals being in place prior to study site initiations and investigational product being provided.
    • Define and implement submission plans in conjunction with regulatory PT lead, clinical trial sub-team members, and participate in sub-team meetings to provide regulatory expertise and status updates.
    • Represent RA at clinical trial sub team meetings, identify needs and issues to the cross functional team.
    • Liaise with CRO regulatory contact, managing information/document needs and exchanges, agree upon submission strategy, ensuring the CRO is clear upon company deadline expectations.
    • Utilise CRO regulatory contacts to seek regulatory intelligence that will be beneficial to sub team discussions and strategy, maintaining regulatory relationships with counterparts.
    • Contribute to quality management, implementation of best practices and SOPS for CTA related activities.
    • Work with cross-functional team members to resolve issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution.
    • As a member of the global regulatory affairs team, contribute to process improvements, and inspection readiness amongst the department.
    • Maintain up to date knowledge of CTA related regulatory requirements and communicate in a timely manner any updates that may impact into the development programmes.
    • Develop and maintain CT regulatory intelligence data particularly related to oncology products.
    • Plan & schedule own activities as well as those of the RA Clinical Trial group members.
    • Support non-CT related RA project work as requested.

    The ideal candidate profile will hold an MSc or PhD in a Life Sciences degree and 6 years relevant industry experience within a Pharmaceutical, Biotechnology or CRO environment.

    As a growing organisation, they are always keen to offer incoming employees the scope to evolve and develop and will offer the opportunity to work cross functionally to support continual personal development.

    The package on offer is very competitive in relation to the market and the client is also flexible on home working.

    If this position looks to be of interest, apply now to discuss further.

  • Clinical Operations

    Competitive
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    Skills Alliance is currently partnered with the leading global medical device company based in the central German part of Switzerland. For this purpose, our client is looking for a Senior Clinical Trial Manager to join their team on a permanent basis.

    Job Title: Senior Clinical Trial Manager

    Job Type: Permanent


    Job Description:

    The Senior Clinical Trial Manager is a full-time position that independently implements and oversees all areas of clinical trial management in Europe, North America or other regions as needed. This includes, but is not limited to, managing day-to-day activities including trial start-up, conduct, and closeout activities on (multiple) clinical trials as well as management of vendors such as Contract Research Organizations (CROs) and/or investigative sites. The Sr. Clinical Trial Manager is highly self-motivated, pro-active and flexible. This position is field-based and reports to the Director of Clinical Operations.

    Essential Duties & Responsibilities:

    • Consistently implement and successfully completes clinical research operations in global clinical trials.
    • Ensure that the assigned clinical trials are conducted in accordance with internal Standard Operating Procedures, Good Clinical Practice regulations as well as applicable country’s regulations
    • Managing the completion of routine and advanced trial start-up, conduct, and close-out activities to industry and corporate standards, with support from a senior member of the clinical operations team
    • Manages and works effectively with CROs and other vendor partners
    • Establishes and maintains sound clinical and data collection practices to ensure validity of studies
    • Assisting with (or leading, when necessary) the writing of clinical documents such as informed consents, trial reports, and annual reports
    • Follow up and implement clinical site contracts and budgets
    • Responsible for the evaluation and selection of investigative sites
    • Ensuring that the progress and completion of trial(s) are in-line with the agreed upon trial goals/ targets such as enrollment, active sites and other milestones, as determined by the manager
    • Planning, Implementing and tracking of trial timelines and budgets
    • Managing most aspects of trial operations including vendor performance, internal metrics, and communication of trial status within and outside the trial team
    • Train and mentor clinical operations team members such as junior CTM and CRAs.
    • Lead the preparation and follow-up of in-house and on-site sponsored quality audits, co-monitoring visits with CRO monitors, as well as, regulatory authority inspections.
    • Organize and participate in investigational meetings and site training representing assigned clinical trial
    • Preparing and presenting trial specific updates to management and cross functional areas
    • Manages Clinical Operations team members to appropriate and timely completion of projects
    • Ensure activities comply with the applicable Quality System requirements
    • Assume any other activities and responsibilities as assigned

    Required Skills & Competencies:

    • Familiarity with clinical research in Oncology
    • Strong critical thinking and problem solving skills
    • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
    • Excellent organizational and record-keeping skills
    • Ability to maintain excellent working relationships with a broad range of trial staff internally and externally
    • Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
    • Ability to work well in a team environment but also independently without significant oversight
    • Experience in clinical budget planning, management, and reconciliation required; forecasting experience preferred.
    • Prior experience with electronic data capture (EDC) preferred
    • Experience interfacing and managing multiple vendors/contractors.
    • Strong initiative and positive attitude.
    • Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information.
    • Flexibility in work hours and readiness to travel abroad on as needed basis
    • Fluency in English (verbal and written) and excellent communication skills
    • Advanced computer literacy

    Qualifications:

    • Bachelor’s degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school preferred
    • Minimum 5-7 years of experience in a clinical trials management role in the device, biotechnical and/or pharmaceutical industry monitoring and managing clinical trials. Device experience preferred or trial management in a biotech/start-up environment.
    • Minimum of 6 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
    • 5-7 years of oncology experience preferred
    • Oncology solid tumor experience preferred
    • Accredited GCP course desirable
    • Past experience in an administrative position desirable

    Other:

    • Average travel commitment of 25-30%, which includes overnight travel as needed (United States and abroad)
    • Ability to lift up to 20 pounds

    If you are interested or you know someone who would be interested please apply directly here or feel free to contact Heena Verma via phone @ +41 44 798 2410.

    Thanks!

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    £600 - £700 per day
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    Skills Alliance are supporting a global pharmaceutical organisation with an ongoing procurement transformation programme. As part of this programme, they are implementing a brand new P2P solution across their global business.

    Within this project team, they require an experienced P2P Change Management professional to join on an initial 12 month contract.

    Job Purpose:

    • To lead change initiatives across the global P2P implementation.
    • Manage stakeholder expectations across a wide range of internal functions up to a senior level – This may include leadership across procurement, finance, IT, compliance, legal, to name a few.
    • Manage the relationship with external 3rd parties supporting the implementation.
    • Be the point of contact and subject-matter expert on any changes to processes, system differentiators between old and new.
    • Ensure key individuals and functional users are content with changes, along with managing timeline expectations.

    Required experience:

    • A proven track record managing several P2P implementations is essential, either as a change manager or project manager in job title. A project manager will need to have a strong focus on change/transformation.
    • Tier-1 P2P system experience – SAP Ariba, Oracle e-fusion, Coupa, or equivalent level.
    • Global P2P system implementation experience is required.
    • Demonstrable experience working in a complex, matrix-structured organisation.

    Note: Due to current restrictions, this will be a remote-based role until further notice.

    Please get in touch with Jim Bellicoso at Skills Alliance for further information! jim.bellicoso@skillsalliance.com.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Regulatory

    £50000 - £60000 per annum
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    Regulatory Affairs Executive

    My client is currently looking for someone to join their team as a Regulatory Affairs Executive and be responsible for UK specific regulatory oversight on marketed products.

    This is a great opportunity for someone looking to enhance their knowledge and experience on QRVI systems and processes, as well as representing the Regulatory function and contributing with advice on different strategies to improve quality performance.

    Responsibilities:

    • Advising on local strategy procedures
    • Acting as the primary regulatory liaison between MHRA and OPUK
    • Submission of variations to the MHRA ensuring maintenance of regulatory databases
    • Organise internal audits for the affiliate

    Requirements:

    • Degree in Pharmacy or life science degree
    • Good knowledge of QMS, GDP, GMP, GCP, Regulatory
    • Experince in interacting with the MHRA
    • Excellent attention to detail and flexible approach

    This is a site-based position in Berkshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £40000 - £50000 per annum
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    QMS Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QMS Specialist.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop systems and establish procedures for documentation
    • Ensure that current QA documentation is in line with relevant requirements
    • To provide direct Quality team support during audits and inspections
    • Provide Quality systems and training

    Requirements:

    • Experience with HTA is essential
    • Experince within GMP environment
    • Knowledge and expertise in the QMS processes
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Medical affairs

    £40000 - £50000 per annum, bonus
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    Medical Information and PV Officer – Hybrid Role – Global Pharma

    I am currently working with a client of mine who are looking for a medical information and pharmacovigilance officer to join their team.

    My client are a globally renowned pharmaceutical company, well known for their work within the cardiovascular and oncolog therapeutic areas. They are a mid-sized company, continually growing and are invested in the development of their employees giving this person ample opportunity to progress within the business.

    For this position, my client is ideally looking for someone who is experienced in both medical information and pharmacovigilance. Your responsibilities will include responding to first and second line enquiries as well as carrying out copy approval. With this in mind, copy approval experience is essential.

    This role will also encompass responsibilities such as working with European affiliates to ensure policies are in line with ABPI, EFPIA and IPHA codes of practice so this is a great role allowing you to take on EU exposure.

    As part of the pharmacovigilance responsiblities, you will be deputy local safety officer, responsible for a breadth of pharmacovigilance duties such as reporting ADRs, training junior PV staff in the team as well as proof-reading SMPCs and PILs to ensure compliance with safety data.

    This is a great role for anyone with some experience in a similar role to this to step up and take on more responsibilities to further your career.

    For more information on this position or any similar opportunities, please contact Chanel Hicken on 0207 220 6206.

  • Quality

    £30000 - £40000 per annum
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    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Share

    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Commercial

    Competitive
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    As a Training & Development Manager for you will be responsible for the delivery of training across the UK, Ireland, Nordics & Netherlands Teams.

    The role will see you leading product training for several new indications of the product portfolio, including adapting regional programmes; working closely with the Sales Forces to identify training / development needs and put in place suitable solutions as well as designing & delivering soft skills training. The role will see you working with internal stakeholders across all levels as well as where required outsource partners for learning solutions.

    You will have a proven track record in delivering training within a Pharmaceutical industry setting. This should be beyond soft skills training and include specifically product / scientific based training.

    You experience will include some or all of the following:

    Good understanding of the ABPI code of Practice.
    Proven track record of delivering high quality training related work with tangible outcomes.
    Good understanding of speciality therapeutic areas
    Able to get on with others and be a team-player having the ability to work within a team and independently.
    Ability to function in and influence key stakeholders in matrix organisation.

    For more information on this opportunity or any similar opportunities, please contact Warda Issa or email your CV and we can arrange a time for a confidential discussion about your next career move.


    T: +44 (0) 203 823 4158

  • Quality

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Share

    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £45000 per annum
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    Share

    Document Control Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a Document Control Specialist.

    You would be part of a rapidly growing Quality Assurance team, with the opportunity of having complete autonomy over the role, while helping them manage all document control activities within the company. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop a documentation system and establish procedures
    • To create standard templates for QMS controlled documentation
    • To track and issue-controlled documents including SOPs and protocols
    • To interface with other departments regarding documentation related activities


    Requirements:

    • Excellent Documentation Control in a GMP environment
    • Vast documentation practice and principles of Data Integrity
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £40000 - £50000 per annum
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    Share

    QMS Specialist

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QMS Specialist.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To develop systems and establish procedures for documentation
    • Ensure that current QA documentation is in line with relevant requirements
    • To provide direct Quality team support during audits and inspections
    • Provide Quality systems and training

    Requirements:

    • Experience with HTA is essential
    • Experince within GMP environment
    • Knowledge and expertise in the QMS processes
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £30000 - £40000 per annum
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    Senior Quality Associate

    Currently partnering with a leading global contract service company who are currently looking for a Senior Quality Associate to join their rapidly growing team.

    This is very exciting opportunity for an experienced Quality professional with an extensive background in Good Manufacturing Practice to develop and manage quality projects, as well as working cross functionally to implement new processes. The role is with a well-established company, with very strong company culture, offering excellent long-term prospects.

    Responsibilities:

    • To liaise with project teams as a key quality contact
    • To provide advice to cross-functional teams
    • To ensure SOPs are up to date
    • To ensure CAPAs, Complaints, Deviations and Change Controls are managed and reviewed
    • To perform risk assessments

    Requirements:

    • Minimum 3 years’ experience working within the QA function
    • Extensive knowledge of Quality Assurance and GXP guidelines
    • Excellent communication skills
    • Ability to make timely and quality decisions
    • Strong time management and organisational skills


    This is a permanent and full-time position, with a competitive salary on offer.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    Competitive Salary + Benefits
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    Senior Manager, GCP Quality

    I have exclusively partnered with a Cell & Gene Therapy organisation to hire a Senior Manager, GCP Quality Assurance to join their growing team.

    With a promising pipeline, the company plans to rapidly transform their work into breakthrough therapeutics, primarily focusing on cancer and diabetes.

    This position will be responsible for supporting the Head of GCLP Quality with all related GCP activities, ensuring the highest quality standards are in place and adhered to within the organisation. The Senior Manager will conduct QA oversight and assist in the development and implementation of GCP Quality Systems.

    Responsibilities:

    • To support with the implementation and maintenance of GCP Quality Systems
    • To train and mentor staff on global GCP guidelines
    • Lead and manage GCP inspections
    • Conduct QA oversight


    Requirements:

    • BS in Biological Sciences or related degree
    • Minimum 5 years of relevant experince working with GCP guidelines
    • Extensive experince with GCP inspections
    • Good time management and organisational skills
    • Excellent communicator


    This is an office-based position based in Cambridge, MA. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £35000 - £40000 per annum
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    Quality Assurance Officer

    This is a great opportunity to join a very ambitious, award winning cell therapy start-up, currently looking for a QA Officer.

    You would be part of a rapidly growing Quality Assurance team, supporting them with the implementation of their Quality Management Systems. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the biotech industry.

    Responsibilities:

    • To support the Quality Assurance team with related QA activities
    • To implement and maintain Quality System processes and GMP guidelines
    • To support SOPs and associated documents
    • Schedule and plan internal audits


    Requirements:

    • Experience with HTA is essential
    • Sterile or Aseptic experince, desirable
    • Good Manufacturing Practice within a Pharmaceutical environment
    • Good time management and organisational skills
    • Excellent communicator

    This is an office-based position based in Cambridgeshire. It is a permanent role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Quality

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • Procurement

    £400 - £425 per day
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    Skills Alliance are working with a global pharmaceutical organisation, undertaking major change across their international business. As part of this programme, they are seeking an experienced P2P Business Analyst to support process change across their existing procurement systems.

    The Job:

    The global transformation programme across the business is aimed to standardise operating processes and deploy a global SAP IT platform. It includes:

    • One integrated set of master data
    • Finance & Accounting, Procurement, and Supply Chain operations
    • Core HR processes, KPIs and HR data management

    This role is key to the delivery of the EMEA solution, which at present is scheduled for completion in approximately March 2021 and will deploy to 28 countries.

    You will be required to provide core Business Analysist support in the following P2P areas:

    • Processes – SAP Concur T&E, Ariba Sourcing, Contracts and Supplier lifecycle performance, Ariba Guided Buying, Invoicing (Invoice Pro), Ariba Network (Supplier Onboarding), Supplier Master, SAP S/4 Hana
    • Business Audience – end users and requesters, approvers and managers, Outsourced operation teams, Finance and Procurement
    • Business Analysis / Change
    • Training and Change team support
    • Development of EMEA Business Roles permissions and transactions – from both an Ariba and SAP perspective – Effectively aligning the users to appropriate roles and responsibilities.


    Required Experience:

    • Strong P2P process, change and business analysis background preferred.
    • End User centric, approach with excellent verbal and written communication skills is required.
    • Solid practical knowledge of P2P in Ariba, SAP AP and some masterdata is required.
    • Degree educated
  • Regulatory

    COMPETITIVE
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    Skills Alliance are currently partnered with an innovative Biotech focusing on ATMPs who is looking for Sr. Regulatory Affairs Associates to join their growing team. They have been progressing well with early phase studies and have cutting edge programs in phase II.

    This position will report into the Director, Regulatory Affairs and will support in the development, review and execution of regulatory strategy within the regulatory sub-team and the delivery of regulatory activities/submissions necessary to support global product development and registration.

    Requirements:

    • Biological sciences degree
    • Up to 4 years’ experience in regulatory affairs
    • Experience of European and US regulatory affairs

    This role provides a rare opportunity to join at an exciting phase of growth.

    Please submit your CV if you are interested in discussing further.

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    Skills Alliance are currently partnered with an innovative Biotech focusing on ATMPs who is looking for Sr. Regulatory Affairs Associates – CMC to join their growing team. They have been progressing well with early phase studies and have cutting edge programs in phase II.

    This position will manage the CMC regulatory submissions throughout the lifecycle with minimum supervision, with responsibility for the authoring, reviewing, compiling and execution of all regulatory CMC submissions.

    Requirements:

    • Scientific background in ATMPs or biologics
    • A degree in Biosciences, Biochem, Chemistry would be a plus
    • Ideally worked in a small pharma/biotech environment
    • Experience working on Change Controls.
    • Someone who has pushed themselves out of their comfort zone to progress their career.

    This role provides a rare opportunity to join at an exciting phase of growth.

    Please submit your CV if you are interested in discussing further.

  • Clinical Operations

    £60000 - £70000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £60000 per annum, Bonus + benefits
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    Great opportunity for an experienced Senior / Lead CRA or Junior Study Manager to join a niche Bitoech working in advanced therapies. The role would be home-based initially with some travel to an office when normality resumes!

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior / Lead CRA or Junior Study Manager who is keen to work in both science and operations. Early phase Lead CRA or project management expeirence would be preferable and some international experience.

    This is a permanent and full-time role. The role would be home-based initially with some travel to the office in the long-run. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Pre-Clinical

    £90000 - £100000 per annum, car allowance + bonus + benefits
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    Director, Computational Biology position with a World-class Pharma, permanent position, home-based in the UK initially and a few days in Hertfordshire further down the line.

    Rare opportunity to join one of the World’s leading pharmaceutical companies with a superb reputation in the market. Their pipeline and products cover a wide range of areas and they are investing in their Computational Biology division which is an innovative and growing group.

    They are recruiting for a Director, Computational Biology role at present. They are looking for an experienced individual who is keen to come in and lead a group (5-6 people initially) but growing so extensive line management is required.

    Requirements:

    • PhD background
    • Experience leading computational biology/bioinformatics approaches, focused on genomic data analysis or translational bioinformatics
    • Ability to leverage multi-omic data sets to drive biological insights.
    • Experience of genetic/genomic approaches in target identification and validation would be preferred.

    This is a permanent and full-time position. The role is based in their office in Hertfordshire (with flexibility 2-3 days) but everyone is home-based at present with the COVID situation. The salary would be able to offer is around £90-100K for Director depending on experience + car allowance + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please contact Mark Anderson for more details on 0207 220 6209 or click APPLY NOW.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established SME Pharma. Permanent Associate Clinical Study Manager role based from home initially but 3 days in Hertfordshire in the future.

    This SME Pharma work in Oncology and are recruiting specifically for their Oncology team. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Lead CRA, Associate Study Manager or Regional Study Manager to join the team and will consider CRO or Pharma experience. Oncology experience is required as a CPM or CRA.

    This is a full-time and permanent position. It is home-based initially but will be office-based in Hertfordshire with flexibility further down the line. They offer an excellent salary and package around GBP 55-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Commercial

    Competitive
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    An exciting opportunity for an experienced life science brand/marketing specialist to join an global pharmaceutical company specialising in Neurology. You will be developing, implementing and leading marketing strategies global, working across the EMEA. This is a highly strategic position that requires those who have experience working above country level alongside launch experience.

    My client is a globally renowned biopharmaceutical company covering a number of indications within Neurology. As part of this international company, you’ll have the opportunity to gain international exposure to further expand your niche skillset in the field of Neurology and will be working alongside some of the world-leading experts in this field. Although a global company, they are still going through a huge period of growth at the moment with an ever-growing pipeline, thereby giving you the opportunity to progress your career quickly once within the business.

    Requirements:

    · Educated to Degree Level ideally in Life Sciences
    · Launch experience required, above country level
    · Proven experience and success in specialist area, preferably Neurology
    · Previous specialist sales experience desired
    · Demonstrable experience and success working in a matrix environment
    · International experience and cultural sensitivity
    · Good knowledge of European codes of practice, especially ABPI desirable

    For more information on this opportunity or any similar opportunities, please contact Warda Issa or email your CV and we can arrange a time for a confidential discussion about your next career move.


    T: +44 (0) 203 823 4158