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  • £40000 - £50000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visits

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

    This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

    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.

  • £20000 - £27000 per annum
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    Quality Control Analyst

    This is a great opportunity to join a well-established Pharmaceutical firm, with an extremely strong culture and great opportunities for career progression.

    They are currently looking for a passionate QC Analyst to join their growing QC team and contribute to the development of a variety of medicines and healthcare products.


    Responsibilities:

    • Assisting with the Quality Control of raw materials

    • Working in accordance with prescribed guidelines

    • Working with different analytical techniques

    Requirements:

    • 1 year’s relevant experience in an analytical testing role

    • Experience working with HPLC and GC analysis

    • Excellent communication skills

    This is an office-based position based in Hertfordshire. It is a permanent role offering a competitive salary up to 25K, 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.

  • £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a European-based 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:

    • Coordinate qualification and routine requalification in the sterile processes
    • Knowledge of sterile and aseptic technical processes
    • Developing analytical methods
    • Implementing CAPAs

    Requirements:

    • 3+ years of experience in leading investigations
    • HPLC, GMP, GLP knowledge
    • 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 Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • £26.79 per hour, PAYE Benefits
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    Skills Alliance are working with a global pharmaceutical company, currently undergoing an international transformation programme across various shared service functions. As part of this programme along with managing processes amidst the current pandemic, they are seeking a Payroll Management Specialist to join the business on an initial 3 month contract. You will be required to have experience of payroll oversight (e.g. NIC, tax codes etc) and knowledge of SAP/ NGA/ADP payroll systems.

    Job Purpose:
    To effectively manage and lead a team of payroll officers and facilitate the smooth running of the company’s Payroll Services and transition to NGA Payroll.

    Required Experience:

    • Experience of Payroll oversight e.g. NIC, tax codes etc.
    • Knowledge of SAP/ NGA/ADP payroll systems
    • Proven compliance expertise; to understand and comply with industry laws and relevant regulations
    • Demonstrable examples of ability to proactively promote best practice and knowledge sharing.
    • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
  • €60 - €100 per hour
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    Skills Alliance are working with an innovative Medical Device company, currently within the Research & Development phase. As part of their growth they are seeking a Senior R&D engineer to join the business on an initial 6-month contract. You will be required to have experience with class IIb and III implantable medical device (catheter experience preferred).

    Responsibilities:

    – Prototyping of proposed designs

    – Development and documentation of manufacturing processes to support new designs

    – Contribute to compliance with Design Control regulations

    – Supporting and guiding the clinical team

    – Proficiency in SolidWorks and CAD experience

    Please contact: Shakir Hossain
    Email: shakir.hossain (at) skillsalliance.com
    Phone: + 44 (0) 207 220 6232

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    A leading pioneering software medical device company are currently on the market for a VP of Regulatory Affairs. With the company within its pivotal moment in its history and following the launch of a new program, the VP would overlook and be accountable for the overall Regulatory Affairs function.

    Responsibilities:

    • Provide strategic vision, expertise and leadership in the development of products and regulatory approval in the UK, Europe, US and then worldwide.
    • Responsibility for the company’s compliance with regulatory agencies and all applicable standards worldwide
    • Input as needed into the clinical studies required for Regulatory Approvals. Conversant in the key aspects and able to work with in-house and external experts in medical statistics, clinical study design, and data analysis.
    • Provide training and interpretation of FDA and other regulatory issues across the company more generally
    • Be responsible for the review and approval of promotional, advertising, and labelling items as and where necessary
    • Lead the Compliance to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.

    Requirements:

    • Demonstrate significant regulatory experience and strategic thinking in novel situations.
    • Proven experience of achieving regulatory approvals for Software as a Medical device in the EU and USA.
    • A commercial focus in the application of regulatory requirements.
    • Outstanding communication skills, both verbal and written, and the ability to interface effectively with software engineering, operations, sales and marketing, and a wide range of other stakeholders
    • Bachelor’s or higher degree, preferably in life sciences, engineering, or business desirable

    The VP of Regulatory Affair is a permanent role offering a competitive salary and benefit package located in Cambridge.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi or for more details click APPLY NOW

  • Rate on application
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    A global pharmaceutical company are recruiting for a Payroll Specialist 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 project. They are looking for a contractor to manage and lead a team of payroll officers and facilitate smooth running of company’s payroll services with the following respomnsibilies:

    Responsibilities:

    • Payroll – Manage relationship with current Payroll Provider and ensure a successful implementation of new payroll with NGA
    • Manage UK Payroll Team on review, improving process and policies.
    • Guide and support the team on the process, dealing with issues and queries.
    • Ensure team meets key deadlines on annual timetables and compensation activities.

    Requirements:

    • Must have NGA knowledge and experience
    • Experience of Payroll oversight e.g. NIC, tax codes etc.
    • Knowledge of SAP/ NGA/ADP payroll systems
    • Proven compliance expertise; to understand and comply with industry laws and relevant regulations

    This role is an office-based position in South East England. It is a 3-month contract role on an competitive hourly rate.

    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.

  • €600 - €800 per day
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    I have a unique opportunity to join developing biotech focused on cell therapy as an Interim Associate Director of Clinical Operations.

    This is an office-based position located 30 minutes South of Brussels.

    They are looking for this individual to be responsible for the overall coordination of the clinical team and monitoring of daily activities to ensure the successful completion of clinical trials. Exposure and participation in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH–GCP Guidelines and SOPs.

    Additionally to supports overall management of the department in collaboration with senior management. Reports to the VP of Clinical Development.

    Experience required:

    ▪ 10+ year’s relevant experience in clinical operations.
    ▪ Considerable depth of experience in clinical study management, monitoring, and developing study-related documents.
    ▪ Management experience required – will be responsible for a team of 12. ▪

    Must be french speaking I look forward to speaking with those interested.

    +44 (0)2072206235

    My email is (No spaces) jack . sinclair (@) skillsalliance . com

  • Competitive Pay
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    We are partnered with a forward thinking CRO in the Greater Seattle area in search of a Histology Technician. This company’s mission is to enhance human life through therapeutics, and they have a focus on animal welfare and the humane treatment of their animal models. This person will work on the preparation of quality tissue samples for histopathologic evaluation; identification of tissue samples for proper embedding orientation; microtomy skills; performance routine hematoxylin and eosin (H&E) staining procedures; knowledge of the use and maintenance of equipment used for the preparation of tissue samples and the ability to maintain a clean and orderly laboratory environment.

    Responsibilities

    • Maintain and document the use and maintenance of laboratory equipment
    • Microtomy daily
    • Performs paraffin tissue processing
    • Identifies required tissue sample orientation and performs paraffin embedding procedures
    • Uses microtomy skills in the preparation of routine (paraffin embedded) microscopic slides according to standard operating procedures and/or required by study protocols
    • Performs routine hematoxylin and eosin (H&E) staining as well as cover slipping microscopic slides

    • Requirements:
      Associate’s degree (AA), specializing in science, preferred
    • Work experience includes, but not limited to at least 1+ years laboratory experience and/or training HT (ASCP) eligible within one year of employment

    This position is moving quickly so do not hesitate to apply!

  • Competitive Pay + Benefits
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    Title: Medical Director

    Location: New Jersey

    I’m partnered with a boutique pharmaceutical company just launched in the US, who is a global leader in the treatment of iron deficiency anemia in humans and animals.

    With Global HQ in Denmark and a product recently approved by the FDA, they are now looking for a Medical Director who can help them grow in the U.S. Ideally, they would like this person to have experience in hematology or oncology and if you’ve expertise specifically within anemia that is a plus but not essential.

    Responsibilities/Requirements

    • Experience with teams/organizations expanding into new markets
    • Therapeutic area experience: Hematology or Oncology required
    • Experience within Anemia a plus
    • Exciting opportunity to grow a new division for a newly approved FDA product

    We’re moving very quickly with this role, please don’t hesitate to apply as soon as possible. Please also feel free to reach out directly to Christine.Erickson@skillsalliance.com.

  • Competitive Pay + Benefits
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    We are partnered with a growing Companion Diagnostics in Seattle, working on state-of-the-art technology, and revolutionizing cancer diagnostics and monitoring through their novel approach to Next Generation Sequencing. Their goal is to bring this technology to as many cancer patients at possible.


    They are looking to grow the team with a Regulatory Manager who has experience with medical devices, as they are on their way to FDA approval.


    Role and Responsibilities:

    • Evaluate proposed products for product classification and regulatory pathway.
    • Assess regulatory intelligence in the development of regulatory strategies.
    • Develop and maintain Regulatory Strategy/Plan.
    • Develop regulatory procedures and SOPs and participates in implementation.
    • Manage submission activities for a variety of device regulatory approvals including CE mark, US premarket approvals (PMAs), US Premarket Notifications 510(k), post-approval reports, export certificates, establishment registrations, and device listings.
    • Review labeling and promotional material.


    Qualifications and Skills:

    • Bachelor’s degree.
    • At least 6 years of direct experience in the diagnostic industry, including a minimum of 5 years of Regulatory Affairs experience.
    • Experience in writing and preparing Regulatory Documents required.

    This position is moving quickly so do not hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    Location: Greater Boston Area

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for executing legislative and advocacy strategies in the US Congress, federal agencies and with other stakeholders This role requires someone who can think strategically while working in a hands-on manner, as well as someone who can engage both internal and external stakeholders.

    Requirements:

    • Bachelor’s Degree; Advanced Degree in healthcare/policy is strongly preferred
    • Minimum 10+ years of relevant experience. Minimum 3-5 years in a government body relevant to healthcare policy
    • Experience with lobbying trade associations, industry groups, and/or working on Capitol Hill or another legislative or administrative body
    • US specialty biologics and biosimilars experience preferred
    • Can travel domestically and internationally approximately 40% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible

  • Competitive Pay + Benefits
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    We are partnered with a Companion Diagnostic Company in Seattle that is transforming care for cancer patients by providing genomic analysis of the disease using non-invasive liquid biopsy methods. Their assay platform has been validated to detect all four major types of genetic alterations that cause cancer! They are seeking an experienced Senior Full Stack Engineer for their team. You’ll be architecting and developing essential software systems that support the IVD development and local R&D projects, as well as facilitate integration with clients and research partners. This is a great opportunity to work for an exciting growing company who will truly make an impact in people’s lives.

    • 5+ years professional experience in software development

    • Experience gathering requirements and user acceptance required

    • React and/or React Native based development

    • Full stack development in a serverless environment using AWS, AWS core services

    • REST API design and development using Node.JS Express

    • Git / GitHub Flow

    • TDD

    • Kanban and/or SCRUM type practice, Jira/Trello

    • Ubuntu / Amazon Linux flavorings

    We are moving quickly on this position so do not hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    Location: Boston, MA

    We are currently partnered with a pioneering biosimilars company who are focused on making medications easily accessible across some of the greatest healthcare needs. They are looking to hire key leadership positions to help successfully launch their US business.

    In this role, you would be responsible for managing all channels of the market access, and establishing relationships with payers in the U.S. This role requires a true strategic thinker, as well as an individual who thrives in a hands-on, growing environment.

    Requirements:

    • Bachelor’s Degree; advanced degree in health management / business is strongly preferred.
    • Minimum of 10-15 years’ experience in US pricing / market access, commercial or finance in the pharmaceutical industry is required.
    • Strong knowledge of the U.S. managed markets including commercial and government payers as well as other channels like Specialty Pharmacies, ACOs, IDNs etc.
    • Can travel domestically and internationally approximately 50% of the time

    We are moving very quickly with this role, so please do not hesitate to apply as soon as possible.

  • Competitive Salary + Comprehensive Benefits
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    We are currently partnered with a Swedish-based Medical Technology company looking to revolutionize how ADHD is assessed and diagnosed. They are focused in on creating informed decisions, combining both subjective and objective data, allowing for a more accurate diagnosis.

    Looking to continue their mission, and secure clinical utility studies in the US that will strengthen the medical necessity for tests, they are looking for a Clinical Research Head to join their team. This role will be responsible for all ongoing Clinical Research projects, and ensuring their success.

    Requirements:

    • Extensive experience in Clinical Trials methodology and/or Neurodevelopmental Disorders
    • Global Clinical Trials Experience
    • Medical Device/Technology experience preferred
    • Documented capacity to write scientific reports and papers
    • Strong interpersonal and communication skills
    • Previous Leadership experience

    We are moving very quickly with this role, so please don’t hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    I’m working a confidential search with a pioneering biotechnology company working to expand the human healthspan by slowing and reversing age related diseases. Working at the forefront of biotechnology and medicine, their main mission stands behind extending our health unburdened by the disease of aging.

    In this role would, you would play a crucial part in experimental design and execution, analysis and interpretation of data, and presentation of findings to the larger Discovery organization. You would have a truly important role in the critical selection of clinical development candidates.

    Requirements:

    • Bachelor’s degree in the Life Sciences with 6-10 years of scientific experience in the biopharmaceutical industry, a Master’s degree and 2-6 years of experience, or a PhD in a relevant research field
    • Direct experience in developing in vitro assays (both cellular and biochemical)
    • Preferred experience in primary cell culture and/or co-culture models
    • Preferred experience in antibody screening and discovery

    We are moving very quickly with this role, so please don’t hesitate to apply!

  • Competitive Salary + Comprehensive Benefits
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    We are confidentially partnered with a pioneering biotechnology company working to expand the human healthspan by slowing and reversing age related diseases. Working at the forefront of biotechnology and medicine, their main mission stands behind extending our health unburdened by the disease of aging.

    For this role, you will have strong experience in experimental design, tissue handling, immunohistochemistry and digital quantitative analysis of histological images all supported by a solid background in histological technique and theory.

    Requirements:

    • Bachelor’s or associate’s degree in medical technology, clinical laboratory, chemical, physical or biological science and at least 4 years relevant work experience.
    • Experience performing histological stains, IHC / IF, or ISH on mouse and human tissue utilizing both manual and automated platforms.
    • Experience with slide imaging and fluorescence microscopy.
    • Experience with image quantification and analysis.


    We are moving very quickly with this role, so please don’t hesitate to apply!

  • £30000 - £40000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visit

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

      This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

      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.

  • £30000 - £40000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visit

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

      This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

      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.

  • £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 in late phase.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Late Phase team to work on a wide variety of trials. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. The candidate would need phase III or phase IV experience and be interested in observational studies.

    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 preferred 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.

  • £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 in cell and gene therapy, specifically in Oncology.

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

    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.

  • £70000 - £80000 per annum, excellent package
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    A very exciting opportunity to join a growing Biopharma. Permanent Late Phase Associate Director / Program Manager role based in West London offering an excellent salary and package.

    This exciting and innovative Biopharma have many products on the market and a very strong pipeline. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Program Manager or Associate Director, this would be working on a variety of late phase phase studies. They require a substiantial clinical trial management background, line management and strong and recent non-interventional trials experience.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work from home. They offer an excellent salary and package around GBP 75-90K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this Clinical Program Manager / AD position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • £50000 - £60000 per annum
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    A Leading global Pharmaceutical company are recruiting for a Senior Manager Global Quality Operations in Hertfordshire.

    This is a unique opportunity to improve the company’s quality systems, inspection management, regulatory intelligence activities and many more.

    Responsibilities:

    • Pharmacovigilance Audits – Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities

    • Plan, supervise, conduct, and support internal and external GxP audits

    • Maintain a tracking tool for audits, findings and corrective and preventive actions

    • Quality System

    • Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’

    • Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV.

    • Collaborate with the respective Functional Area Heads/representatives

    • Ensure SOPs/ WPs are compliant with applicable requirements and regulations

    • Support the preparation for GxP inspections

    • Support the responses to Regulatory Authorities

    • Regulatory Intelligence – Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of the company’s procedures.

    Requirements:

    • Degree in natural science or equivalent number of years’ experience

    • Experience in Pharmacovigilance auditing (Qualification as an auditor preferred)

    • Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation

    • Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance

    • Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

    • Exposure to inspections

    This Senior Manager Global Quality Operations position is an office-based position. It Is a permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details at
    0203 668 3961 or click APPLY NOW

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    A Global Pharmaceutical company focusing on the manufacturing and distribution of Generics through the differing business arms allowing them to provide medicinal solutions from production through to supply chain.

    This organisation is currently going through some expansion plans, diversifying their portfolio and looking at new countries, in which to offer solutions to more patients.

    With this in mind they are currently looking to recruit a Senior QA Manager – Auditor with the following experience:

    • Work on internal/external GMDP audits covering Third-Party Manufacturers, Laboratories, Warehouse and Logistics.
    • Complete QTAs
    • Stability Report Reviews
    • Risk Assessments
    • Work with CMOs

    If this role looks to be of interest and you would like to have an informal conversation to discuss your current situation and whether this position aligns well with your career progression plans, please submit your CV and I will contact you with more information

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    Skills Alliance are currently partnered with a Global Specialist CNS Pharmaceutical company who is increasing their Manufacturing and as a result searching for an experienced QP to join their team.


    Key Responsibilities

    • Qualified Person as defined in Article 51 of 2001/83/EC
    • Responsible for ensuring that all medicinal products are manufactured to the requirements of EU GMP
    • MHRA and FDA Inspections
    • Lead internal/external quality audits

    Requirements

    • Knowledge of EU GMP, regulations and guidelines.
    • Managing QMS Systems
    • Experience in sterile and non-sterile dosage forms
    • BSc degree in Life Sciences.

    This Qualified Person position is a permanent position and comes with a competitive salary + benefits. Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW.

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    Skills Alliance is currently partnered with the leading global pharmaceutical company based in the UK. For this purpose, our client is looking for a Local Study Manager/Project Manager to join their team on a permanent basis.

    This is a permanent employment with a global mid-sized CRO and a 1 year contract (to begin with a possibility of extension) with the Sponsor (a leading global pharmaceutical company).

    Please refer Job Description below:-

    Must have Criteria/Requirements:-

    Experience in working managing studies for Oncology trials within the UK.
    Project Management experience is a MUST along with experience in managing CRA’s is also a MUST.
    Budget management experience is nice to have but is not a deal breaker.
    You should ideally able to be based in Luton office for 1-2 days per week – rest of the days is Home-office.

    Responsibilities:-

    • Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
    • Lead local study team(s) consisting of CRAs, lead CRAs (if Nordic countries outside Sweden participate in the study) and study administrator(s).
    • In collaboration with Line Manager(s):
      • Lead and optimize the performance of the local study team(s) at country level verifying compliance with AZ procedural documents, ICH-GCP and local regulations and to update other study team members on study matters
      • Lead development of local monitoring plan as per targeted monitoring guidance from respective study team.
      • Perform any required co-monitoring and QC visits with study monitor(s)
    • Contribute to review of monitoring visit reports and pro-actively advice the CRA(s) on study related matters.
    • Proactively identify and facilitate resolution of complex study problems and issues.
    • Organize regular local study team meetings on an agenda driven basis.
    • Actively work towards achieving good relationships with all local study team members.
    • Report study progress/update to the SMO study leader/team.
    • Contribute to patient recruitment strategy with monitors, including regular communication with concerned investigators as necessary.
    • Communicate and co-ordinate regularly with national coordinating investigator/national lead investigator on recruitment and other study matters.
    • Coordinate the process for selection of potential investigators considering capability, competence, etc. of the hospitals/sites.
    • Plan and lead national Investigator meetings, in line with local codes.
    • Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
    • Work in close coordination with study drug coordinator to create a robust drug consumption plan.
    • Oversee timely preparation of country SMA, country fSMA and country master CSA.
    • In collaboration with the local study team, verify completeness of the electronic trial master file and/or paper trial master file on country and site level, and confirm essential documents are sent to SMO/hub location/site.
    • Oversee timely submission of proper application/documents to EC/IRB.
    • Work together with regulatory affairs to see to timely delivery of proper application/documents for submissions to regulatory authority.
    • Set up and maintain the study in CTMS and/or other clinical trial management system, at study country level.
    • Confirm accurate payments related to the study are performed.
    • Participate in training and coaching new members of the local study team.
    • Verify that all study documents are ready for final archiving and sign-off completion of local part of the trial master file.
    • Plan and lead activities associated with audits and regulatory inspections in liaison with line manager, clinical process manager and CQM.
    • Provide input to process development and improvement.
    • Provide regular information to SMM Director and Associate Directs(s) at country level on studies and planned study milestones/key issues.
    • Update SMM Director and Associate Directs(s) about the performance of the CRAs/lead CRAs and CSAs in the local ST.
    • Confirm that study activities at country level comply with AZ’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
    • Assist SMM Director and Associate Directs(s) in efficient functioning of department at country level.
    • Prepare and maintain study budget at country level in ACCORD.
    • Liaise with local compliance officer and nominated signatory regarding payments to investigators to confirm these are in accordance with local requirements.
    • Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
    • See that clinical and operational feasibility assessment of study design concept and clinical study protocol is performed to highest quality.
    • Support SMM region in initiatives as agreed with SMM Director and Associate Directs(s).

    If interested, or you know someone who would be interested please apply directly here or contact Heena Verma via phone: +41 44 798 2410.

  • £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.

  • £30000 - £40000 per annum
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    Quality Systems Associate

    This is a great opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Quality Systems Associate.

    You would be part of a global, well-established and well-known Pharma organisation, which specialises in neurology and oncology. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the company’s vision within the healthcare industry.

    Responsibilities:

    • To support QMS Indicator reports

    • To coordinate GMP training

    • To support improvements to TrackWise processes and systems

    • To support the Deviation System

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Good technical and analytical judgment

    • Ability to maintain a professional behaviour

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 30K-40k, depending on experience.

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

  • £30000 - £40000 per annum
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    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a QC Analyst position.

    You would be part of a well-established and well-known Pharma organisation, which specialises in the treatment of addiction and critical care. 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:

    • Carrying out analysis of finished products and stability batches

    • Working alongside the technical team

    • Developing analytical methods

    • Working according to GMP standards

    Requirements:

    • 2+ years of relevant experience

    • HPLC, GMP, GLP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal and communication skills

    This Quality Control Analyst 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.

  • £30000 - £38000 per annum
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    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a QA Team Leader.

    You would be part of a well-established and well-known Pharma organisation, and as the company expands their manufacturing plans, you will have the capability to progress within your career, as well as contribute towards reaching the companies targets and vision.


    Responsibilities:

    • Oversee the quality of the entire product journey
    • Working alongside the Quality Systems Department
    • Generating the departmental KPIs as required by the business
    • Ensure that all staff members are trained and aware of the importance of GMP guidelines


    Requirements:

    • Previous managerial experience/ leading a team
    • Prior experience working with GMP and GDP standards
    • Previous managerial experience
    • Experience with regulatory GMDP audits
    • Excellent interpersonal and leadership skills


    This QA 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.

  • Competitive
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    A global medical device company are recruiting for a HR Business Partner based in North West of London. This is an opportunity to join a reputable Medical Device company that are looking for a business partner who will be carrying out the following responsibilities:

    Responsibilities:

    • You will work across the full range of the HR function, and partner with managers and local HR to understand the key performance issues, objectives and drivers and in order to proactively drive the HR agenda.

    Requirements:

    • Demonstrated ability to consult, influence, and partner with senior leaders to drive business performance
    • Demonstrated relationship management skills at all levels of the organisation as well as team management
    • Experience in Organisational Design and creating High Performing Organisations.
    • Degree qualified or equivalent, ideally CIPD qualified.

    This is a 6-month contract role on a competitive day rate.

    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.

  • Rate on application
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    A multinational medical manufacturing company are recruiting for a Service Now Consultant III based in North West London for a 6 month (100% remote) contract. This role is an excellent opportunity for a driven individual to work within a large, complex Transformation Programme, leading the delivery of one of the key technology solutions.

    The Service Now Consultant will be responsible for working with a number key stakeholders and third parties to successfully deliver the changes to Service Now Platform. In addition to managing and executing the project level plans to achieve the overarching Programme delivery. The Incumbent will play a key role in understanding the status, risks and issues at the project level and then reporting this into the overall Programme.

    Requirements:

    • Proven experience (5 years+) project managing SaaS and PaaS solutions, with specific knowledge in architecting solutions for ServiceNow
    • Significant experience in the delivery of design documentation addressing business requirements and translating those requirements to application development teams
    • Knowledge of ServiceNow/ITIL modules, particularly HR case management and the use of that technology in a similar large corporate organisation
    • Experience in designing and implementing complex, multi-tier, multi-tenant, end-to-end solutions in a high availability environment.
    • Proven success on projects with large-scale deployments; understanding of application life-cycle management.
    • Ability to work globally, with management of remote and distributed project teams

    This role is a 6 month contract on an excellent hourly rate. 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.

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    A leading global Pharmaceutical company are currently recruiting for a Safety Evaluation and Risk Management – Pharmacovigilance manager based in London. The role sits in the pharma safety group which supports all aspects of the safety profile of the company’s medicine portfolio both in development and post marketing.

    In this role you will join a team engaged in early post marketing activities for one of the recently launched respiratory medicines. The pace is very dynamic with some opportunity to work flexibly across different projects.

    Key Responsibilities:

    • Provide high level scientific expertise in the safety evaluation and risk management of GSK medicines either in clinical development and/or the post-marketing.
    • Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives
    • Support the disease area or product area safety strategy at internal company cross functional meetings and may represent the company externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
    • Participate in pharmacovigilance and risk management planning in the clinical matrix.
    • Plan and prioritize activities for designated products
    • Lead safety input into regulatory benefit-risk assessments and the preparation of Risk Management Plans
    • Deliver the clinical safety input into clinical development planning activities
    • May represent clinical safety on cross functional Clinical Matrix Teams and/or Project Teams.
    • Contribute to cross-functional ad hoc teams to address urgent and important product safety issues
    • Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
    • May lead or participate in discussion at Global Safety Board for safety related findings.
    • Escalate safety signals appropriately as identified through the Safety Review Process

    Additional responsibilities in Signal Detection, Evaluation, Labelling and submissions

    • Requirements:
    • Prior experience in pharmacovigilance including aggregate reports and risk management activities.
    • Strong evaluation skills and analytical thinking
    • Medical writing skills
    • Sound knowledge of relevant pharmacovigilance regulations and methodologies applicable to safety evaluation and risk management activities
    • Track record of quality decision making, and problem resolution based on assessment of all relevant supporting and conflicting information/factors
    • Experience in managing complex tasks in a matrix team setting.
    • Degree in Biomedical or Health Care related specialty

    This role is based in London and comes with a competitive base salary + benefits package. Skills Alliance are the preferred supplier for this role. For more information or to apply please contact Ibraheem Idrissi on 0207 220 6204 or quick APPLY NOW!

  • Regulatory Affairs Director

    This is an exciting opportunity for someone with extensive Regulatory Affairs background to join a pioneering Biotech company to hire a Director, Regulatory Affairs for a 12-month fixed term contract to join their organisation.

    With a very strong pipeline, their current focus is to move from Phase III to commercialisation, with the intention to supply globally. This position will facilitate interfacing between internal and external stakeholders of the organisation and being the main point of contact with all regulatory bodies to assist the process of approving the product to market. The Regulatory Affairs Director will also create and implement different regulatory strategies and will effectively communicate and manage other partnering organisations as appropriate, while assisting with all Regulatory matters.

    Responsibilities:

    • Coordinate and prepare meetings with regulatory agencies
    • Oversee the regulatory collaboration with CROs
    • Drive collaboration with the Legal and Compliance Team
    • Write and amend electronic submissions to facilitate regulatory agency requests

    Requirements:

    • Bachelor’s degree in Life Science/ advanced degree preferred
    • Strong verbal and written communication skills
    • Strong strategic-thinking and organisational skills
    • Prior experience working on an EU regulatory procedure

    This is a 12-month fixed term contract position based in London with full-time working from home until current national restrictions change, and a great 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 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.

  • 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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    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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    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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    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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    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

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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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    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.