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  • Clinical Operations

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    Skills Alliance is currently partnered with the leading global mid-sized CRO. For this purpose, our client is looking for a Clinical Research Associate (CRA) to join their team.

    All roles are Sponsor based- leading Global Pharma company.

    1) CRA Ophthalmology (Fully remote) Either to be based in Barcelona or Madrid: This involves national travel. At least 3 years of experience working as a CRA within therapeutic area Ophthalmology. Freelance CRA (minimum 0.4 FTE-0.5 FTE is needed – the client is also open for more FTE.

    2) Jr. CRA (office based) : Permanent role: To be based in Madrid Spain: involves national travel; Atleast 6 months of experience as a CRA.

    3) CRA (partial remote: To be based in Barcelona: Permanent Role: involves regional travel. Atleast 1 year of working as a CRA independently.

    4) CRA: Fully remote: to be Based in Galicia, Spain: Permanent Role: involves regional travel. Atleast 1 year of working as a CRA independently.

    If interested or you know someone who would be interested please apply directly here or email at heena.verma@skillsalliance.com or phone @ +41 44 798 2410.

    Thanks!

    Best,
    Heena Verma
    Recruitment Consultant, Europe | Clinical Operations | Zürich

  • Clinical Operations

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    Skills Alliance is currently partnered with the leading global mid-sized CRO. For this purpose, our client is looking for a Clinical Research Associate (CRA) to join their team on a permanent role.

    This role is to be based in Milan, Italy.

    2 roles:

    1) You have to be based in Milan, Italy: CRA Junior: This involves national travel. At least 6 months of experience working as a CRA (with certificate)

    2) Fully remote: You can be based anywhere in Lombardy region: CRA Oncology: (national travel) – At least 18 months of experience working as a CRA (with certificate, involved in some oncology studies). Our client is considering candidates who are even with other therapeutic area but with some experience within oncology.

    If interested or you know someone who would be interested please apply directly here or email at heena.verma@skillsalliance.com or phone @ +41 44 798 2410.

    Thanks!

    Best,
    Heena Verma
    Recruitment Consultant, Europe | Clinical Operations | Zürich

  • Clinical Operations

    Competitive
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    Skills Alliance is currently partnered with the leading global mid-sized CRO. For this purpose, our client is looking for a Clinical project Manager to join their team on a permanent role.

    This role can either be based in Barcelona or Madrid.

    RESPONSABILITIES:

    • Active participation in the preparation of Clinical Development plans
    • Collaboration in the elaboration and review of clinical trials outlines, DSUR, IB, and international (Europe/FDA) submission dossiers.
    • Participation and reporting to the Project Team (PT), Medical Sub Team (MST), Core Teams and, any other team as needed.
    • Participation in advisors, partners or in- and out-licences meetings, including the preparation and review of associated documentation.
    • Collaborate in the creation of presentations for congresses and/or papers for medical journals based on CT results.
    • Planning and conduct of clinical trials/experimental and cosmetic testing/investigations with medical devices, including preparation, review or approval of all associated documentation (synopsis, protocol, report, timelines, all study plans –statistical, data management, monitoring,…-, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
    • CRO and other vendors selection for the outsourcing of Clinical Trials and other activities task according to Project needs.
    • Leadership and coordination of the different areas and activities of the “Clinical Study Team.
    • Cooperation with other department representatives when needed: Global Sourcing, Pharmacokinetics and Metabolism, Biology, Pharmacology, Regulatory Affairs, Marketing, GMA-MA, Corporate Global Drug Safety, Pharmaceuticals, Affiliates, Intellectual Property, Quality Assurance, Global Clinical Leader and Global Safety Leader.
    • Participate in the preparation of any documentation related to competent national and local authorities, and the relevant ethics committees, coordinate and boost regulatory submissions and answer to their questions.
    • Organize and/or participate in the Investigators Meeting/Pre-initiation visits/Kick-off Meetings presenting the protocol and study operational aspects (study drug, monitoring) of the study, and visit research sites ad-hoc
    • Supervise and boost sites activation and recruitment progress, database cleaning, and timely SAE reporting.
    • Review of the Trial Master File key documents related to activities under CTM direct responsibility.
    • Collaboration in the planning and conduction of audits and CAPA implementation, and in the inspections to the participating sites or sponsor.
    • Ongoing review of CT blinded data (e.g. for identification of protocol deviations, ensuring accuracy of data cleaning, early detection of unexpected trends on patients baseline characteristics).
    • Leadership of the “Blind Data Review Meeting”.
    • Ensuring the CT are conducted in accordance with Good Clinical Practices (GCPs), with applicable international quality standards, with the agreed SOPs, policies and standards, as well as any other guidelines given by the Head of Global Clinical Operations (GCO) and GCL.
    • Report and discuss with the Medical sub team Escalation to the GCL and/or Project Manager and Head of GCO any significant deviation (or a risk for deviation) from the agreed timelines, budget, qualitative metrics or standards at any time during the trial.
    • Continuing education and training on medical and clinical research topics, national and international policies for the development of CT.
    • Collaboration in SOPs update/creation/training.


    REQUIREMENTS

    Diploma in Nursing and/or Graduate in Health Sciences (Pharmacy, Biology, Biochemistry and/or Medicine and Surgery).

    · Participation in Clinical Trials
    · Must have experience within clinical studies from site initiation until close-out
    · Pharmaceutical Industry business
    · Project Management
    · Basic Statistics and/or Biometry
    · Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
    · Others: Preferably Doctor’s degree
    · English essential (Other languages desirable)

    If interested or you know someone who would be interested please apply directly here or email at heena.verma@skillsalliance.com or phone @ +41 44 798 2410.

    Thanks!

    Best,
    Heena Verma
    Recruitment Consultant, Europe | Clinical Operations | Zürich

  • Medical affairs

    Competitive
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    Skills Alliance is currently partnered with the leading global mid-sized CRO based in Madrid. For this purpose, our client is looking for a Medical Specialist to join their team on a permanent role.

    FUNCTIONS:

    – Coordination of the development of projects from a scientific and clinical point of view.
    – Design and maintenance of the protocols of the studies sponsored by the assigned company, as well as review of their design and execution in their scientific, clinical and methodological aspects.
    – Preparation of the clinical section of documents required in clinical research (Informed Consents, Investigator’s Manuals, Aggregate Reports, etc.
    – Review and analysis of clinical trial data from the clinical point of view and its reporting in the final reports.
    – Participation in the selection of centres and investigators participating in clinical trials.
    – Medical responsible for the protocols under his/her responsibility, providing the necessary clinical support for their correct follow-up.
    – Collaboration in the communication of results in scientific publications and congresses.
    – Support to the Regulatory Affairs Area in the documentation related to the marketed product from a scientific point of view and to the Marketing and Business Development Department.

    REQUIREMENTS:

    – Degree in Medicine
    – High level of English (other languages are a plus)
    – At least 2 years’ experience in similar positions or in other positions within Medical Affairs and/or Clinical Research departments is desirable.

    If interested or you know someone who would be interested please apply directly here or email at heena.verma@skillsalliance.com or phone @ +41 44 798 2410.

    Thanks!

    Best,

    Heena Verma
    Recruitment Consultant, Europe | Clinical Operations | Zürich

  • Clinical Operations

    $95000 - $135000 per annum
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    I am working on a unique opportunity to join a pioneering and well-established research facility.

    I am working with a US based company specialising in paediatric Oncology, ranking in the top 5 paediatric research centres in America. They have numerous ground-breaking treatments ranging from Cystic Fibrosis to immuno-oncology therapies.
    I am supporting the recruitment of a CTM 2 and a Senior CTM, hiring across Seattle, Georgia, Texas and Florida.

    The Trial Manager will be responsible for full oversight of single and multi-site clinical trials, guaranteeing the research projects are carried out in compliance with applicable federal and local regulations. Management and mentoring of clinical sites, resources, and vendor(s) as applicable.

    The right candidate must demonstrate experience in leading teams in a matrixed environment, with in depth knowledge of trial management, developing study material (protocols, plans, manuals) and evaluating site performance against established criteria. Phase 1 & 2 clinical research experience is also required. A good understanding of oncology is strongly preferred.

  • Clinical Operations

    $95000 - $135000 per annum
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    I am working on a unique opportunity to join a pioneering and well-established research facility.

    I am working with a US based company specialising in paediatric Oncology, ranking in the top 5 paediatric research centres in America. They have numerous ground-breaking treatments ranging from Cystic Fibrosis to immuno-oncology therapies.
    I am supporting the recruitment of a CTM 2 and a Senior CTM, hiring across Seattle, Georgia, Texas and Florida.

    The Trial Manager will be responsible for full oversight of single and multi-site clinical trials, guaranteeing the research projects are carried out in compliance with applicable federal and local regulations. Management and mentoring of clinical sites, resources, and vendor(s) as applicable.

    The right candidate must demonstrate experience in leading teams in a matrixed environment, with in depth knowledge of trial management, developing study material (protocols, plans, manuals) and evaluating site performance against established criteria. Phase 1 & 2 clinical research experience is also required. A good understanding of oncology is strongly preferred.

  • Clinical Operations

    $95000 - $135000 per annum
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    Job
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    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    I am working on a unique opportunity to join a pioneering and well-established research facility.

    I am working with a US based company specialising in paediatric Oncology, ranking in the top 5 paediatric research centres in America. They have numerous ground-breaking treatments ranging from Cystic Fibrosis to immuno-oncology therapies.
    I am supporting the recruitment of a CTM 2 and a Senior CTM, hiring across Seattle, Georgia, Texas and Florida.

    The Trial Manager will be responsible for full oversight of single and multi-site clinical trials, guaranteeing the research projects are carried out in compliance with applicable federal and local regulations. Management and mentoring of clinical sites, resources, and vendor(s) as applicable.

    The right candidate must demonstrate experience in leading teams in a matrixed environment, with in depth knowledge of trial management, developing study material (protocols, plans, manuals) and evaluating site performance against established criteria. Phase 1 & 2 clinical research experience is also required. A good understanding of oncology is strongly preferred.

  • Clinical Operations

    $95000 - $135000 per annum
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    Job
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    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

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


    Share

    I am working on a unique opportunity to join a pioneering and well-established research facility.

    I am working with a US based company specialising in paediatric Oncology, ranking in the top 5 paediatric research centres in America. They have numerous ground-breaking treatments ranging from Cystic Fibrosis to immuno-oncology therapies.
    I am supporting the recruitment of a CTM 2 and a Senior CTM, hiring across Seattle, Georgia, Texas and Florida.

    The Trial Manager will be responsible for full oversight of single and multi-site clinical trials, guaranteeing the research projects are carried out in compliance with applicable federal and local regulations. Management and mentoring of clinical sites, resources, and vendor(s) as applicable.

    The right candidate must demonstrate experience in leading teams in a matrixed environment, with in depth knowledge of trial management, developing study material (protocols, plans, manuals) and evaluating site performance against established criteria. Phase 1 & 2 clinical research experience is also required. A good understanding of oncology is strongly preferred.

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours or haematology. Study responsibility and line management of a small team.

    This is a great opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This growing Pharmaceutical company works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager with international trial management experience. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Development

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Pre-Clinical

    £60000 - £80000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies. *PHARMA EXPERIENCE REQUIRED*

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Project Management

    £60000 - £78000 per annum, Bonus + benefits
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    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies. *PHARMA EXPERIENCE REQUIRED*

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has strong budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-77K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    $135000 - $170000 per annum, + 20% profit share scheme
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    I have a rare opportunity within a small and niche company who are currently growing in the US.

    They have a focus in Oncology, Immunology, Rare and Neurodegenerative diseases. They have achieved over 50 market authorizations to date. Since their inception in 2004, they pride themselves on providing a highly individualised service for their clients, because of this, they have seen consistent growth across the globe. Using first-in-class technology platforms alongside relationship driven flexibility ensures a high level of service. There are office locations globally, spanning across North America, the UK, Europe and Australia.

    I am working to hire a Senior/AD Project Manager role with a strong focus on external facing business development. This role will be directly involved with the senior management of the company, involved in strategic decision making with the growth and development of the company in mind. The right candidate will display complete proficiency in all aspects of full-service Project Management in Phases I through IV in Oncology, with a preference for candidates with experience in any of: immunology, neurology, CAR-T or gene therapy.

    The role offers home working flexibility, with a minimal need for travel, only travelling when necessary. As such, this role is open to candidates across the whole of the US. The role reports directly into VP level.

    You can expect a salary range from $135k-$170k with an excellent benefits package. There is a big emphasis on a healthy work life balance, providing flexibility with PTO.

    Do you know anyone who would be open to discuss further details?

  • Clinical Operations

    £45000 - £55000 per annum, + company profit share, depending on levels of experience + benefits
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    I have a rare opportunity within a small and niche company who are currently growing in the UK.

    They have a focus in Oncology, Immunology, Rare and Neurodegenerative diseases. Theyhave achieved over 50 market authorizations to date. Since their inception in 2004, they pride themselves on providing a highly individualised service for their clients, because of this, they have seen consistent growth across the globe. Using first-in-class technology platforms alongside relationship driven flexibility ensures a high level of service.

    There are office locations globally, spanning across North America, the UK, Europe and Australia. They are looking for an experienced CRA to join the team at either CRA II or Senior CRA level, it is a wide ranging role working closely with the senior management (including CEO) so great exposure and you would be one of two CRAs in the UK with around 7 site visits on average per month.

    The main focus in the initial stages of the role will be looking Infectious Diseases but they have Oncology projects coming up too. They are big on work/life balance and offering great support to their staff, hence they have very low turnover.

    This is a permanent and full-time position, offering full time working from home, with the exception of site visits as mentioned above. They also have an office in the South East. You can expect a salary ranging between £45,000-£55,000 + company profit share, depending on levels of experience + benefits. They would like someone to start in January ideally, or sooner.

    Would you be keen to discuss this role further? Or can you recommend anyone, if not?

  • Medical affairs

    €100000 per annum, attraktives Bonuspaket, gute Altersvorsorge,
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    Wir suchen aktuell für einen unserer Kunden, ein internationales und wachsendes Biotech Unternehmen, auf der Suche nach Verstärkung für das MSL Team im Bereich der Onkologie.

    Das sind Ihre Aufgaben:

    • Aufbau und Indentifikation aber auch vor allem Weiterentwicklung von Experten und medizinsichen-wissenschaftlichen Zentren
    • Aufbau eines stabilen Netzwerks an KOLs im Indikationsgebiet Onkologie
    • Enge Zusammenarbeit mit den wissenschaftlichen Abteilungen innerhalb des Unternehmens
    • Teilnahme und Organisation von internationalen und nationales Kongressen, Symposien und AdBoards
    • Unterstützung bei internen und exterenen Studienprojekten

    Das bringen Sie mit:

    • Abgeschlossenes naturwissenschaftliches Studium im Bereich Pharmazie, Chemie, Biologie
    • Optimalerweise bringen Sie bereits Erfahrung als MSL in der Onkologie mit und sind auf der Suche nach dem nächsten Schritt
    • Sie arbeiten gerne in crossfunktionalen Teams
    • Sie bringen sehr gute Gesprächs-/ und Kommunikationsfähigkeiten in deutscher und englischer Sprache mit
  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Quality

    Competitive
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    Möchten Sie ein wenig frischen Wind in Ihre Karriere bringen? Derzeit ist ein modernes Unternehmen mit Standort in Darmstadt, welches im Bereich Pharma/Biotech tätig ist, auf der Suche nach einem Quality Assurance Manager (m/w/d).

    Ihre Aufgaben sind:

    • Mitarbeit bei der Aufrechterhaltung, Überwachung und Weiterentwicklung des Qualitätsmanagement – Systems
    • Erstellung, Review, Verwaltung und Archivierung von lokalen Qualitätsdokumenten
    • Bearbeitung weiterer qualitätssichernder Prozesse
    • Ansprechpartner für qualitätsbezogene Fragestellungen
    • Mitwirken bei der Bearbeitung von Kunden- und Marktreklamationen
    • Sicherstellen der termingerechten Durchführung und Dokumentation von Qualitätsprüfungen

    Folgende Qualifikationen treffen auf Sie zu:

    • Pharmazeutische, naturwissenschaftliche Ausbildung oder ein abgeschlossenes Studium (z.B. Pharmazie, Biologie, Biochemie, Chemie, Medizin oder Naturwissenschaften)
    • Einschlägige Berufserfahrung im Bereich Qualitätssicherung
    • Gute konzeptionell analytische Denk- und Arbeitsweise
    • Ausgeprägte Kommunikationsstärke
    • Selbstständige, eigenverantwortliche und sorgfältige Arbeitsweise
    • Sehr gute Englischkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, zögern Sie nicht uns zu kontaktieren!

  • HR and talent acquisition

    £45000 - £55000 per annum
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    A leading Pharmaceuticals company is seeking a Talent Acquisition specialist to report into their UK head office. The internal recruitment partner will be responsible for building talent pipelines throughout Europe and is required to have fluent German-language skills.

    In return, this forward-thinking organisation offers an entrepreneurial environment where innovation and creative thinking is highly rewarded. They offer an array of employee benefits including reduced working hours, full-time remote working available, annual bonuses and incentives.

    Responsibilities include:

    • Direct sourcing of candidates for vacancies from junior to senior executive level
    • Talent pipelining throughout europe
    • Building employer brand within the market place
    • Contribution to the overall growth and development of the talent acquisition function
    • Partners with the wider business and hiring manager to understand recruitment needs
    • Contributes ideas and uses initiative to work independently

    Requirements:

    • Life Sciences recruitment experience
    • German language skills
    • Accountable and pro-active in their approach to their work

    Please contact Sarah Brambill on 0207 220 6218 or sarah.brambill@skillalliance.com for more information about this opportunity or apply NOW for immediate consideration.

  • Regulatory

    €80000 - €100000 per annum, Gute Sozialleistungen und Altersvorsorge
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    Unser Kunde, ein internationales Biotec Unternehmen, ist auf der Suche nach einem erfahrenen „Regulatory Affairs Manager“ im Rhein-Neckar Gebiet. Es handelt sich hierbei um eine Festanstellung und bietet anderweitig sehr ansprechende Konditionen. Wenn Sie die folgenden Aufgaben ansprechen, freuen wir uns sehr auf Ihre Bewerbung:

    • Die Zusammenarbeit mit den Zulassungsbehörden fällt Ihnen leicht und ist Ihnen bestens vertraut
    • Sowohl die Dossierarbeit als auch die Arbeit im CCDS liegt Ihnen und bereitet Ihnen auch zukünftig Freude
    • Sie arbeiten eng mit den Bereichen Pharmakovigilanz und Drug Safety zusammen
    • Mithilfe bei der Durchführung von Audits
    • Erstellung von Produktzertifikaten und Administrationen der Zertifikatsdatenbank

    Ihre Qualifikationen:

    • Sie bringen langjährige Erfahrungen in der Zulassung für die Produkte der pharmazeutischen oder Biotec Industrie mit
    • Sie haben Ihr Studium im Bereich Pharmazie o.Ä. erfolgreich abgeschlossen
    • Sie bringen einschlägige Berufserfahrung in der pharmazeutischen oder Biotec Industrie mit
    • Sie bringen sehr gute (muttersprachliche) Kenntnisse in Deutsch, sowie sehr gute Kenntnisse in Englisch mit (in Wort und Schrift).

  • Clinical Operations

    $90000 - $125000 per annum
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    I am partnered with a World-class SME organisation at present to hire multiple Clinical Safety Manager roles – from Safety Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements and they are a diverse and flexible employer.

    They are looking for an individual with several years of experience of clinical safety or pharmacovigilance within a CRO environment. The ideal candidate will currently be working under the same or closely aligned job title. Project management experience is preferred. Full proficiency within reviewing protocols and assessing all safety aspects of clinical trials. Weekly sponsor meetings to maintain clarity on on-going projects, ensuring set timelines are met.

    This position is remote for experienced candidates, however its is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. Direct reports are dependent on seniority and WFH arrangements. You can expect a salary range between $90k-$125K + bonus with excellent benefits.

  • Clinical Operations

    $90000 - $140000 per annum, + bonus + excellent benefits
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    I am partnered exclusively with a World-class SME organisation at present to hire multiple Start-up roles – from Start-up Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements, and they are a diverse and flexible employer.

    This role will be the primary point of contact for sponsors, also being involved in kick off/bid defence meetings, thus prior experience is required. The role will be very hand on with projects as opposed to providing just oversight, carrying the full workload of start-up of trials, handling on average 8 projects at any given time. Preferred therapy areas include oncology, cardiology, CNS and neurology but they are flexible, global experience also preferred. Experience levels can vary, looking for at least a couple years experience within an industry setting (ideally 4+ years in CRO). At level II & III there will be line management responsibilities, with AD/D level having additional managerial responsibilities.

    This position is remote contingent on a minimum of 4 years CRO experience, however it is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. You can expect a salary of between $90-$140K + bonus + excellent benefits.

  • CMC

    90000€ - 110000€
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    Regulatory Affairs Abteilung in Big Pharma sucht Zuwachs!

    Unser Kunde, einer der Top 10 Big Players in Pharma, sucht nach einem*r neuen Regulatory Affairs Manager*in an seinem Standort in Süddeutschland. Bringen Sie Erfahrung in Sachen Zulassung, Audits, CMC, PV und Drug Safety mit? Dann freuen wir uns auf Ihre Bewerbung!

    Weitere Aufgabengebiete sind unter anderem:

    • Aufgaben eines*r Informationsbeauftragten in Berücksichtigung von §74a des AMG
    • Durchführung von Audits
    • Aufbereitung und Pflege bereits ausgearbeiteter Zulassungen
    • Dossierpflege
    • Zusammenarbeit mit PV und Drug Safety
    • Hauptverantwortung für die Vereinbarung nationaler wissenschaftlicher Gutachten mit den zuständigen nationalen Behörden
    • Zusammenarbeit mit den europäischen Gruppen für RA und Unternehmen in regulatorischen Fragen
    • Enge Zusammenarbeit mit der Supply Chain, um etwaige Rückstände bei den auf dem Markt befindlichen Produkten zu erkennen

    Diese weiteren Qualitäten sollten Sie für diese Stelle mitbringen:

    • Erfolgreich abgeschlossenes Studium der Pharmazie oder einer anderen relevanten Naturwissenschaft
    • Langjährige Erfahrung in der Arzneimittelzulassung
    • Erfahrung in der Industrie
    • Qualifizierte*r Informationsbeauftragte*r nach §74a AMG
    • Sehr gutes Verständnis der nationalen und internationalen europäischen Arzneimittelregularien
    • Englische Sprache sehr gut in Wort und Schrift, Deutsche Sprache bestenfalls muttersprachlich oder sehr gut in Wort und Schrift

    Erkennen Sie sich in dieser Beschreibung wieder? Bewerben Sie sich!

  • Quality

    Competitive
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    Sind Sie bereit für eine neue Aufgabe?
    Aktuell suchen wir für einen Kunden eine Qualified Person zur Verstärkung der Qualitätsabteilung. Das im Raum Düsseldorf ansässige Familienunternehmen legt besonders großen Wert auf eine offene und moderne Unternehmenskultur und ist bereits seit über 20 Jahren international erfolgreich und am Markt etabliert. Während Agilität wortwörtlich gelebt wird, bietet das Unternehmen außerdem zustätzlich attraktive Benefits.

    Das sind Ihre Aufgaben:

    • Chargenfreigabe von Arzneimitteln
    • Verantwortung für die richtige Durchführung der Produktqualitätsüberprüfung (PQR)
    • Ansprechpartner im Hinblick auf Fragen bezüglich GMP- und regulatorischer Compliance
    • Mitarbeit an der Weiterentwicklung von qualitätsrelevanten Systemen und Prozessen
    • Durchführung von Inspektions- und Validierungsprozessen
    • Mitarbeit bei sämtlichen GMP-relevanten Vorgängen, z. B. Bewer­tung von Ergebnissen und Abweichungen
    • Erstellung und Pflege von SOPs sowie weiteren GMP-rele­vanten Doku­menten
    • Bewertung und Genehmi­gung von Product Quality Reviews

    Das bringen Sie mit:

    • Naturwissenschaftliches Studium, optimalerweise Approbation als Pharmazeut.
    • Sehr gute Kennt­nisse und praktische Erfah­rung im Umgang mit GMP sowie den aktuellen Gesetzen bzw. Verord­nungen
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
    • Verantwortungsbewusste und selbstständige Arbeitsweise
    • Gute analytische Fähigkeiten zur Bewertung komplexer Sachverhalte
    • Hohes Verantwortungsbewsstsein, sowie hohe Teamfähigkeit

    Falls Sie sich angesprochen fühlen, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder per Telefon unter +496950955657.

  • Quality

    Competitive
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    Sind Sie offen für eine neue Herausforderung?

    Aktuell suchen wir für einen Kunden mit Sitz im Raum Düsselsdorf einen Quality Assurance Associate (m/w/d). Das Unternehmen ist seit 70 Jahren am Markt etabliert, bietet eine familiäre Atmosphäre und fokussiert sich auf die Entwicklung und Herstellung von Arzneimitteltherapien.

    Das sind Ihre Aufgaben:

    • Sicherstellen und Überprüfung der Einhaltung von geltenden Vorschriften, internationalen Standards, sowie der Unternehmensrichtlinien, um Komplikationen zu vermeiden
    • Identifikation von Compliance- und Qualitätsrisiken, sowie Berichterstattung
    • Überprüfung von SOPs, Protokollen, Berichten und ähnlichen Dokumenten
    • Dokumentation qualitätsrelevanter Prozesse entsprechend der geltenden Anweisungen, sowie Berichterstattung
    • Mitwirken an der Vorbereitung und Überprüfung von Chargenprotokollen, sowie QA-Aufzeichnungen zur Vorbereitung auf Kundenbesuche
    • Unterstützung von Kundenbesuchen und behördlichen Inspektionen
    • Mitwirken bei der Entwicklung von Korrektur- und Vorbeugemaßnahmen (CAPA)
    • Identifizieren, Dokumentieren und Kommunizieren von Abweichungen
    • Selbstständige Durchführung von Inspektionen und Audits zur Einhaltung von entsprechenden Vorschriften
    • Überprüfung von Materialien und Betriebsmitteln Einhaltung der Standards
    • Mitwirken bei Mitarbeiterschulungen
    • Dokumentation von statistischen Probenahmen und Produktprüfungen
    • Projektunterstützung im Bereich Regulatory Affairs und Compliance.

    Das bringen Sie mit:

    • B.A./B.S. optimalerweise mit biowissenschaftlichem Fokus oder vergleichbare Ausbildung mit entsprechenden Erfahrungen
    • 1-2 Jahre Erfahrung im Bereich Quality Assurance bei einem Pharmaunternehmen oder einer CRO
    • Gute Aufnahme- und Wiedergabefähigkeit
    • Hohes Interesse an Qualitätssicherung und hohe Lernbereitschaft
    • fließende Deutschkenntnisse

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder telefonisch unter +496950988657.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Development

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours or haematology. Study responsibility and line management of a small team.

    This is a great opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This growing Pharmaceutical company works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager with international trial management experience. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Development

    £70000 - £85000 per annum, Excellent package
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    MANAGER / SENIOR MANAGER, CLINICAL SCIENCE / CLINICAL DEVELOPMENT – FAST GROWING ATMP BIOTECH

    This is a great opportunity to join a fast-growing Biotech who do very exciting work in the advanced therapies space. They are doing work across multiple therapy areas at present. This is a superb time to join as they are advancing into phase II studies with their leading program but also other trials in early phase.

    The role is a senior clinical development scientist position, they are flexible on level and need an experienced clinical development or clinical science professional who has good experience of writing and developing clin dev plans and protocols, PhD preferred. It reports into the CMO. They need someone with Oncology experience, ideally from Pharma or Biotech.

    This is a full-time and permanent role. The company is based in the South East but they can offer remote working. They will offer a very good salary and it would depend on the level – around £70-85K depending on experience + bonus + benefits + shares.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details +44 207 220 6209 or APPLY NOW.

  • Clinical Development

    £90000 - £100000 per annum, Excellent package
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    ASSOCIATE DIRECTOR OR DIRECTOR, CLINICAL SCIENCE / CLINICAL DEVELOPMENT – FAST GROWING ATMP BIOTECH

    This is a great opportunity to join a fast-growing Biotech who do very exciting work in the advanced therapies space. They are doing work across multiple therapy areas at present. This is a superb time to join as they are advancing into phase II studies with their leading program but also other trials in early phase.

    The role is a senior clinical development scientist position, they are flexible on level – either Associate Director or Director level and need an experienced clinical development or clinical science professional who has good experience of writing and developing clin dev plans and protocols, working with KOLs and Data review. PhD preferred. It reports into the CMO. They need someone with excellent Oncology experience (ideally ATMP, haematology or Immuno-Oncology), ideally from Pharma or Biotech. No line management.

    This is a full-time and permanent role. The company is based in the South East but they can offer remote working. They will offer a very good salary and it would depend on the level – around £90-100K depending on experience + bonus + benefits + shares.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Apply

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    Im schönen Süddeutschland sucht unser Kunde, ein ‘Big Player’ in Sachen Medizinprodukten, mehrere Manager mit unterschiedlichen Stärken.

    Stellen in diesem Bereich ziehen sich von dem ‘üblichen’ RA Manager Skillset bis zum Fokus auf Europa bis zu Schwerpunkten in Hochrisikoklassen, Compliance, Submission und vielem mehr. Kandidaten aus allen Bereichen der Zulassung im Hinblick auf Medical Devices sind gerne gesehen.

    Überschneidende Aufgabengebiete sind (mit Ausnahmen):

    • Einhaltung und Identifizierung von Regularien in den verschiedenen Schwerpunkten
    • Technische Dokumentation
    • Dossierpflege
    • Korrespondenz mit den zuständigen Behörden
    • Vorbereitung und Unterstützung von Audits

    Je nach Stelle sollte Ihr Profil so aussehen (Abweichungen möglich)

    • Abgeschlossenes Studium im medizinischen/technischen/naturwissenschaftlichem Bereich oder eine vergleichbare Ausbildung
    • Mehrjährige Erfahrung im Bereich Medical Devices (Medizinprodukte)
    • Mehrjärige Erfahrung im Bereich Regulatory Affairs im Hinblick auf Medical Devices
    • Kenntnis von MDD / MDR, MDCG; (REACH & RoHS)
    • Starke Kommunikations- und Teamfähigkeit
    • Gute Kenntnisse in Deutsch und Englisch

    Erkennen Sie sich in der Beschreibung wieder?
    Wir freuen uns auf Ihre Bewerbung!

  • Quality

    Competitive
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    Bereit für eine neue Herausforderung?

    Derzeit suchen wir für einen Kunden im Rhein-Main-Gebiet einen Quality Assurance-/ Regulatory Affairs Manager (m/w/d). Das mittelständige Unternehmen besteht bereits seit knapp 25 Jahren und hat sich auf die Produktion von Medizinprodukten spezialisert.

    Das sind Ihre Aufgaben:

    • Mitgestaltung, sowie Sicherstellung der Einhaltung von unternehmensinternen Qualitätsstandards
    • Stetige Weiterentwicklung des Qualitätsmanagements
    • Mitwirkung bei der Weiterentwicklung, sowie Planung und Regulierung des Qualitätsmanagementsystems und Bearbeitung von relevanten Dokumenten
    • Implementierung von Standardregularien in qualitätsbezogene Dokumente
    • Bewertung von Prüfergebnissen und Planung interner Audits
    • Durchführung interner Qualitätstrainings
    • Überwachung von CAPAs
    • Mitwirkung bei Lieferantenqualifizierungen
    • Chargen- und Dokumentenprüfung, sowie Dokumentenfreigabe
    • Mitwirkung bei Wartungs- und Kalibrierungsprozessen
    • Anmeldung und Zertifizierung von Produkten (national und international)

    Das bringen Sie mit:

    • Abgeschlossenes naturwissenschaftliches Studium in Richtung Chemie, Biologie, Medizin oder vergleichbare Abschlüsse
    • Umfassende Kenntnisse über Gesetze und Regularien bezüglich der Produktion von medizinischen Produkten
    • Erfahrung im Bereich Qualitäts-, Prozess-, Projekt- und Change Management
    • Gute Englischkenntnisse in Wort und Schrift
    • Offene, kommunikative und lösungsorientierte Persönlichkeit

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Medical Devices

    €70000 - €80000 per annum, Gleitzeit, Fahrtkostenzuschuss, Kindergartenzuschuss, Betriebsrente, leistungsgerechte Gehaltsentwicklung
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    Unser Kunde in der schönen Hansestadt Hamburg sucht ab sofort eine*n Regulatory Affairs Manager*in mit Fokus auf Medizinprodukte.

    Bei unserem Kunden handelt es sich um einen mittelgroßen (300-400 Mitarbeiter), in seiner Fachrichtung führenden Medzinprodukthersteller und Anbieter. Für eine Stelle als Regulatory Affairs Manager*in sucht unser Kunde dabei jemanden mit praktischer Expertise in regulatorischen Angelegenheiten gemäß ISO 13485 und MDR. Also besonderer Fokus ist Kenntnis über, sowie einschlägige praktische Erfahrung im Risikomanagement gemäß ISO 14971, sowie technischer Dokumentation unabdingbar.

    Ihre zukünftigen Aufgaben beinhalten:

    • Pflege und Erstellung technischer Dokumentation
    • Erstellung der Technischen Dokumentation nach dem Inverkehrbringen (PMS und Periodic Safety Update Report)
    • Durchführung und Assistenz von Risikoanalysen sowie Erstellung von Akten im Riskomanagement (ISO 14971)
    • Internationale Registrierungen
    • Cross-sektionale Zusammenarbeit mit anderen Abteilungen (Development, Quality, Clinical Affairs etc.)
    • Vorbereitung, Durchführung und Begleitung von Audits durch Behörden

    So sollte Ihr Profil aussehen:

    • Erfolgreich abgeschlossenes Studium in einem medizinischen, ingenieurwissenschaftlichen, technischen oder allgemein naturwissenschaftlichen Fachgebiet
    • Tiefgehende Kenntnisse in Regulatorische Angelegenheiten im Hinblick auf Medizinprodukte (ISO 13486, ISO 14971, MDR)
    • Praktische Erfahrung und Verständnis in Bereichen der Sterilisation von Medizinprodukten
    • Praktische Erfahrung in Regulatory Affairs für Medizinprodukte
    • Teamfähig
    • Sehr gute Deutsch- und Englischkenntnisse

    Haben Sie Lust, Ihre Erfahrung auf die Probe zu stellen und Teil eines tollen Teams im “Tor zur Welt” namens Hamburg zu werden? Bewerben Sie sich bei uns!

  • Clinical Development

    £65000 - £78000 per annum, Bonus + benefits + shares
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Biotech working in advanced therapies. The role is permanent and the office is based in Central London (with flexibility).

    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 and we have had great feedback from recent placements.

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

    This is a permanent and full-time role. The role would be home-based initially with travel to the Central London office. They offer an excellent salary – GBP 65,000-78,000 + bonus + benefits + shares.

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

  • Quality

    Competitive
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    Bereit für eine neue Herausforderung?

    Derzeit suchen wir für einen Kunden in Süddeutschland einen Quality Assurance Manager (m/w/d). Das moderne und sozial engagierte Pharmaunternehmen hat weltweit über 10.000 Mitarbeiter, besitzt ein vielfältiges Produktportfolio und entwickelt innovative Therapielösungen.

    Das sind Ihre Aufgaben:

    • Feststellen von Abweichungen und entsprechendes CAPA Management
    • Reklamationsmanagement und Durchführung von Product Quality Reviews
    • Durchführung von Personalschulungen im Bereich GXP
    • Mitwirken bei der Pflege, Kontrolle und Weiterentwicklung des Qualitätsmanamenent-Systems
    • Erstellung, Kontrollen, sowie Pflege von qualitätsbezogenen Dokumenten
    • Umsetzung von SOPs und internen Richtlinien

    Das bringen Sie mit:

    • Abgeschlossenes naturwissenschaftliches Studium in Biologie, Chemie, Pharmazie oder vergleichbaren Bereichen
    • Berufserfahrung in GMP-Umfeld und in pharmazeutischen Unternehmen
    • Erfahrung im Bereich Qualitäts-, Prozess-, Projekt- und Change Management
    • IT-Kenntnisse im Bereich Qualitätssicherung
    • Gute Englischkenntnisse in Wort und Schrift, Französischkenntnisse sind vorteilhaft
    • Offene, kommunikative Persönlichkeit
    • produktive und eigenständige Arbeitsweise

    Neben einer attraktiven Grundvergütung und guten Weiterbildungsmöglichkeiten werden zudem nich weitere Benefits geboten.

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Apply

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    Bereit für eine neue Herausforderung?

    Derzeit suchen wir für einen Kunden im Raum München einen Quality-/ Regulatory Affairs Manager (m/w/d). Das mittelständige und äußerst moderne Forschungsunternehmen ist führend im Bereich der Diagnostik verschiedener Erkrankungen und legt großen Wert auf personelle, als auch technische Weiterentwicklung.

    Das sind Ihre Aufgaben:

    • Stetige Weiterentwicklung und Verbessung von Prozessen
    • Funktion als Ansprechpartner für Fragen für die Bereiche Qualitymanagement
    • Teilnahme an externen, sowie Durchführung von internen Audits
    • Unterstützung beim Aufbau eines QM-Systems nach ISO 13485
    • Unterstützung bei der Zulassung von In-vitro-Diagnostika
    • Sicherstellen der Qualitätsstandards unter ISO 15189/ISO 17025

    Das bringen Sie mit:

    • Abgeschlossenes naturwissenschaftliches Studium in Richtung (Human-)Biologie, Biotechnologie, Biomedizin oder vergleichbaren Abschluss
    • Erfahrung im Qualitätsmanagement nach ISO 13485
    • Erfahrungen mit ISO 15189 & ISO 17025 sind von Vorteil
    • Erfahrung in der Zulassung von In-vitro-Diagnostika
    • Erfahrungen mit CAP-Akkredierung ist von Vorteil
    • Fließende Deutsch-, sowie sehr gute Englischkenntnisse in Wort und Schrift
    • Offene, kommunikative und lösungsorientierte Persönlichkeit
    • Effektive und eigenständige Arbeitsweise

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Medical affairs

    €120000 per annum, Neben dem attraktiven Gehaltspaket, bietet unser Kunde Leistungen wie Fitnessstudio, Altersvorsorge etc..
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    Unser Kunde ist ein internationales Pharmaunternehmen, welches in der deutschen Niederlassung, einen Medical Advisor sucht.
    Vor allem im Bereich der Forschung und Entwicklung ist das Unternehmen sehr aktiv und hat sich auf die Fahne geschrieben, mit innovativen Therapien das Leben der Menschen ein wenig besser zu machen. Werden Sie Teil dieses Team und unterstützen Sie die medizinische Abteilung.

    Aufgaben:

    • Sie sind für die Markteinführung und die Aktivitäten nach der Markteinführung medizinischer Ansprechpartner im Bereich Medical Affairs
    • Klärung aller medizinischer Fragestellungen von Patienten, Kostenträgern und Behörden in Bezug auf neue klinische Studien oder Forschungsarbeiten
    • Enge Zusammenarbeit und Support der globalen Brandteams mit medizinischem Fachwissen
    • Entwicklung der globalen Markenpläne aus medizinischer Sicht
    • Unterstützung bei der Vorbereitung von Symposien, AdBoards etc. vor medizinischem Fachpublikum
    • Enge Zusammenarbeit mit den Abteilungen Clinical Research und Regulatory Affairs

    Anforderungen:

    • Abgeschlossenes Medizinstudium oder vergleichbares Naturwissenschaftliches Studium, optimalerweise mit Phd.
    • Sie konnten bereits erste Erfahrung in der pharmazeutischen Industrie vorzugsweise im Bereich Cardiovascular sammeln
    • Wünschenswert sind erste Erfahrungen in der Arzneimittelentwicklung
    • Fließende Deutsch und Englischkenntnisse in Wort und Schrift

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to a lot of expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • HR and talent acquisition

    £55000 - £65000 per annum
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    A global Life Sciences organisation is seeking a Communications Specialist to join their ever-expanding team.
    The Internal Communications Specialist will be responsible for developing the employee communications strategy for the EMEA region to increase employee engagement and strengthen the company’s culture across the region. You will also be responsible for developing the senior leadership communications strategy.

    Responsibilities:

    • Design and execute communications strategy for EMEA region
    • Rollout of corporate communications activities
    • Communications activities for various projects
    • Communications activities for employee events
    • Senior stakeholder management and engagement

    Requirements:

    • 2+ years’ experience working within Life Sciences, ideally a large Pharmaceuticals, Biopharmaceuticals or Medical Devices organisation
    • Degree is business administration, journalism, psychology, human resources or similar
    • Well experienced within internal communications

    This is a fantastic opportunity for a marketing, events or human resources professional with a few years’ experience working within internal communications, to progress into a more senior, strategic role.

    This position can be fully home-based or office-based if you prefer. You will work independently and have full autonomy over your work.

    Please apply directly or contact Sarah Brambill from Skills Alliance for more information.

  • Manufacturing

    Competitive
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    Sind Sie offen für eine neue Herausforderung?

    Aktuell suchen wir für einen Kunden mit Sitz im Raum Düsselsdorf einen Quality Assurance Associate (m/w/d). Das Unternehmen ist seit 70 Jahren am Markt etabliert, bietet eine familiäre Atmosphäre und fokussiert sich auf die Entwicklung und Herstellung von Arzneimitteltherapien.

    Das sind Ihre Aufgaben:

    • Erstellung von technischen- und Validierungsprojektunterlagen und Durchführung von Testvalidierungsverfahren/-protokollen
    • Verwaltung von Validierungsprojektprozessen, einschließlich der Erstellung und Überwachung von Ergebnissen und Zeitplänen
    • Pflege und Bereitstellung von Projektzeitplänen, sowie Koordinierung von funktionsübergreifenden Teams, die an den Ergebnissen des Validierungsprojekts beteiligt sind (z. B. Projektteam, IT, Abteilungsleiter, Lieferanten usw.)
    • Koordinierung von Projektbesprechungen, Lenkungsausschüssen, Workshops und Erstellung der zugehörigen Dokumentation
      (z. B. Sitzungsprotokolle, Projektpläne usw.)
    • Sicherstellung der Einhaltung von einschlägigen behördlichen Anforderungen und Richtlinien, Praktiken und Verfahren der Abteilung (SOPs, Sicherheitsverfahren und Biosicherheitsprotokolle)
    • Durchführung von Analysen und Validierung von Vorteilen innerhalb von Projekten
    • Entwicklung und Umsetzung von Lösungen bei Validierungsproblemen
    • Präsentation des Programms für Validierungssysteme bei internen und externen Audits
    • Erledigung aller anderen Aufgaben, die ihm zugewiesen werden.

    Das bringen Sie mit:

    • Naturwissenschaftliches oder technisches Studium (B.A./B.Sc.) oder gleichwertiger Abschluss
    • 2+ Jahre einschlägige Erfahrung im Bereich Validierung und Qualifizierung in einem GxP- und ISO-regulierten Umfeld
    • Eine gleichwertige Kombination von Ausbildung und Erfahrung kann als zufriedenstellender Ersatz für die oben genannte spezifische Ausbildung und Erfahrung akzeptiert werden.
    • Umfassende Kenntnisse der gesetzlichen Anforderungen, Erfahrungen mit GxP in Bezug auf die Validierung sind von Vorteil
    • Ausgezeichnete organisatorische und analytische Fähigkeiten
    • Teamfähige und flexible Persönlichkeit

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder telefonisch unter +496950988657.

  • HEOR

    €110000 per annum
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    Unser Kunde ist ein internationales Gesundheitsunternehmen, welches sowohl im Bereich der Tier- als auch der Humanmedizin tätig ist. Das Familienunternehmen bietet flache Hierarchien und bietet mit seinen mittlerweile mehr als 60000 Beschäftigten eine vielfältige und inklusive Kultur. Im Bereich Market Access suchen wir aktuell einen erfahrenen Market Access Manager HEOR / HTA.

    Aufgaben:

    • Ausbau und Mitgestaltung des globalen HEOR Teams
    • Sie sind verantwortlich für die Durchführung von GAP Analysen, Cost-Effectiveness Modelle, Budget-Impact Modelle sowie Publikationen
    • Sie werden in interdisziplinären Teams wie z.B. mit Clinical Operations zusammenarbeiten
    • Außerdem sind Sie für das Projektteam der Durchführung der frühen Nutzenbewertung verantwortlich und entwickeln Marktzugangsstrategien für Launch und Marktprodukte


    Anforderungen:

    • Sie haben Ihren Anschluss im Bereich Gesundheitsökonomie, Epidemiologie oder Public Health erfolgreich abgeschlossen
    • Sie konnten bereits erste Erfahrung in der frühen Nutzenbewertung nach AMNOG sammeln
    • Sie bringen Kenntnisse in der evidenzbasierten Medizin mit
    • Sie verfügen über sehr gute Sprachkenntnisse in Deutsch und Englisch, sowohl schriftlich als auch mündlich
  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • CMC

    €60000 - €70000 per annum, Flexible Arbeitszeiten
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    Unser Kunde im schönen Bonn sucht nach Verstärkung in seinem Regulatory Affairs Team. Bei dem Unternehmen handelt es sich um einen Hersteller hochwertiger Arzneimittel aus eigener Forschung und Entwicklung.

    Das sollen Sie mitbringen:

    • 1-3 Jahre Erfahrung Regulatory Affairs für Arzneimittel
    • IT-Kenntnis in Datenbanken, Dokumentmanagementsystemen, sowie MS Office
    • Erfahrung im Umgang mit Dossier-Modul 3 (CMC)
    • Expertise mit nationalen Zulassungsverfahren sowie internationalem Life Cycle Management
    • Erfahrung in der Zusammenstellung von Zulassungsdossierts als eCTD Sequenzen
    • Fließende Englisch- und Deutschkenntnisse

    Das wären Ihre Aufgaben:

    • Erstellung und Prüfungs von Zulassungsdossiers
    • Durchführung von Zulassungsverfahren sowie Life Cycle Management inner- und außerhalb der EU
    • Korrespondenz mit Behörden sowie beantwortung von Mängelberichten
    • Erstellung, Prüfung und Freigabe von Packmitteln
    • Eingabe, Pflege und Überprüfung der Stammdaten in XEVMPD

    Ein Job genau für Sie? Bewerben Sie sich!

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    Im schönen Süddeutschland sucht unser Kunde, ein ‘Big Player’ in Sachen Medizinprodukten, mehrere Manager mit unterschiedlichen Stärken.

    Stellen in diesem Bereich ziehen sich von dem ‘üblichen’ RA Manager Skillset bis zum Fokus auf Europa bis zu Schwerpunkten in Hochrisikoklassen, Compliance, Submission und vielem mehr. Kandidaten aus allen Bereichen der Zulassung im Hinblick auf Medical Devices sind gerne gesehen.

    Überschneidende Aufgabengebiete sind (mit Ausnahmen):

    • Einhaltung und Identifizierung von Regularien in den verschiedenen Schwerpunkten
    • Technische Dokumentation
    • Dossierpflege
    • Korrespondenz mit den zuständigen Behörden
    • Vorbereitung und Unterstützung von Audits

    Je nach Stelle sollte Ihr Profil so aussehen (Abweichungen möglich)

    • Abgeschlossenes Studium im medizinischen/technischen/naturwissenschaftlichem Bereich oder eine vergleichbare Ausbildung
    • Mehrjährige Erfahrung im Bereich Medical Devices (Medizinprodukte)
    • Mehrjärige Erfahrung im Bereich Regulatory Affairs im Hinblick auf Medical Devices
    • Kenntnis von MDD / MDR, MDCG; (REACH & RoHS)
    • Starke Kommunikations- und Teamfähigkeit
    • Gute Kenntnisse in Deutsch und Englisch

    Erkennen Sie sich in der Beschreibung wieder?
    Wir freuen uns auf Ihre Bewerbung!

  • CMC

    €80000 - €100000 per annum, Gute Sozialleistungen und Altersvorsorge
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    Unser Kunde, ein internationales Biotec Unternehmen, ist auf der Suche nach einem erfahrenen „Regulatory Affairs Manager“ im Rhein-Neckar Gebiet. Es handelt sich hierbei um eine Festanstellung und bietet anderweitig sehr ansprechende Konditionen. Wenn Sie die folgenden Aufgaben ansprechen, freuen wir uns sehr auf Ihre Bewerbung:

    • Die Zusammenarbeit mit den Zulassungsbehörden fällt Ihnen leicht und ist Ihnen bestens vertraut
    • Sowohl die Dossierarbeit als auch die Arbeit im CCDS liegt Ihnen und bereitet Ihnen auch zukünftig Freude
    • Sie arbeiten eng mit den Bereichen Pharmakovigilanz und Drug Safety zusammen
    • Mithilfe bei der Durchführung von Audits
    • Erstellung von Produktzertifikaten und Administrationen der Zertifikatsdatenbank

    Ihre Qualifikationen:

    • Sie bringen langjährige Erfahrungen in der Zulassung für die Produkte der pharmazeutischen oder Biotec Industrie mit
    • Sie haben Ihr Studium im Bereich Pharmazie o.Ä. erfolgreich abgeschlossen
    • Sie bringen einschlägige Berufserfahrung in der pharmazeutischen oder Biotec Industrie mit
    • Sie bringen sehr gute (muttersprachliche) Kenntnisse in Deutsch, sowie sehr gute Kenntnisse in Englisch mit (in Wort und Schrift).

  • Drug Safety

    €65000 - €95000 per annum, Betriebliche Altersvorsorge, Vermögenswirksame Leistungen, Flexible Arbeitszeiten und Homeoffice Lösungen
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    Unser Kunde im Schwarzwald sucht in allen möglichen Schwerpunkten von Regulatory Affairs (von Arzneimittel bis Medizinprodukten) ein*n Manager*in als Verstärkung für das familiäre Team. Suchen Sie ein familiäres Unternehmen mit flachen Hierarchien, tollen Benefits und mitarbeiterorientierten Rahmenbedingungen? Dann schauen Sie, ob Sie diese Anforderungen mitbringen:

    • Ein abgeschlossenes Studium im naturwissenschaftlichen/technischen Bereich od. eine vergleichbare Ausbildung
    • Mehrjährige Erfahrung in Regulatory Affairs (Arzneimittel oder Medizinprodukte) in DE, EU und auch außerhalb der EU
    • Ausgeprägte Erfahrung in technischer Dokumentation, sowie CTD Dossiers
    • Fähigkeit zum selbstständigen Arbeiten
    • Fließende Deutsch- sowie sehr gute Englischkenntnisse in Wort und Schrift

    Für spezifische Stellen Werden nach weiteren Kriterien gesucht:

    • Erfahrung (mehr als 3 Jahre) im Bereich IVD-Regulierung und/oder Qualitätsmanagement in der IVD
      Industrie und CE-Kennzeichnung von IVD-Produkten

    ODER

    • Erfahrung in der Biokompatibilität von Medizinprodukten in regulierten Umgebungen nach ISO 10993 Standards
    • Fundierte Kenntnisse in der Erstellung wissenschaftlicher Dokumentationen zu chemischen und/oder biologischen Themen,
      vorzugsweise im Hinblick auf die Wirkungsweise von stoffgebundenen Medizinprodukten

    ODER

    • Hintergrund in Softwaretechnik und mehrjährige Berufs- und Führungserfahrung in einer Position mit Personalverantwortung
    • Erfahrung mit Schlüsselthemen des Life Cycle der Softwareentwicklung, wie z.B. Analyse der Softwareanforderungen,
      Softwarearchitektur, detaillierter Softwareentwurf, Tests (Modul, Integration, System), Wartung
    • Sehr gute Kenntnisse der IEC 62304

    Sind Sie neugierig geworden? Stellen Sie gerne alle Ihre Fragen an fritz.koester@skillsalliance.com oder über LinkedIn an Fritz Köster (https://www.linkedin.com/in/fritzkoester/). Alternativ können Sie sich natürlich auch gerne direkt über dieses Portal bewerben.

  • HR and talent acquisition

    £55000 - £65000 per annum
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    A global speciality pharmaceuticals company is seeking a German speaking Life Sciences recruiter to join their UK-based Talent Acquisition team.

    This is a fantastic opportunity for an internal recruiter with experience working for a global CRO, Pharmaceuticals or Medical Devices company to join a agile, entrepreneurial company.

    The Talent Acquisition Partner will look after hiring primarily for the DACH region.

    Responsibilities:

    • Build and manage strong relationships with hiring managers across DACH region
    • Direct sourcing of applicants
    • Telephone / video interviewing
    • Long term talent pipelining
    • Awareness of competitors and market insights
    • Put forward creative and innovative ideas that support continuous improvement of the talent acquisition function

    Requirements:

    • Experienced Life Sciences recruiter
    • German language skills
    • Recruited across DACH region

    Please apply today or contact Sarah Brambill at Skills Alliance for immediate consideration.

  • HR and talent acquisition

    £55000 - £65000 per annum
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    A global speciality pharmaceuticals company is seeking a Spanish speaking Life Sciences recruiter to join their UK-based Talent Acquisition team.

    This is a fantastic opportunity for an internal recruiter with experience working for a global CRO, Pharmaceuticals or Medical Devices company to join a agile, entrepreneurial company.

    The Talent Acquisition Partner will look after hiring primarily for Spanish and Italian speaking countries.

    Responsibilities:

    • Build and manage strong relationships with hiring managers across DACH region
    • Direct sourcing of applicants
    • Telephone / video interviewing
    • Long term talent pipelining
    • Awareness of competitors and market insights
    • Put forward creative and innovative ideas that support continuous improvement of the talent acquisition function

    Requirements:

    • Experienced Life Sciences recruiter
    • German language skills
    • Recruited across DACH region

    Please apply today or contact Sarah Brambill at Skills Alliance for immediate consideration.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Market Access

    €120000 per annum, Attraktive Altersvorsorge, Jobticket, Flexible Arbeitszeiten
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    Unser Kunde ist ein internationales Biotech-/ und Pharmaunternehmen mit mehr als 10.000 Mitarbeitern allein in Deutschland an unterschiedlichen Standorten. Das Kerngeschäft des Unternehmens ist noch immer der Bereich Humanarzneimittel, wobei sich das Portfolio im Laufe der letzten Jahre immer wieder erneuert und diversifiziert hat. Aktuell suchen wir für das Hauptstadtbüro einen Teamleiter Public Affairs (m/w/d):

    Ihre zukünftigen Aufgaben:

    • Politische Positionierung des Unternehmens: Weiterer Auf-/ und Ausbau der politischen Verbindungen zu beispielsweise nationalen Regierungen, Parteien und Verbänden.
    • Enge Zusammenarbeit mit den unterschiedlichen Arbeitsgruppen und Unterstützung bei der Lobbyarbeit
    • Monitoring von aktuellen Gesetzgebungsverfahren und Initiativen aus der Politik

    Sie bringen diese Qualifikationen mit:

    • Mindestens 5 Jahre Berufserfahrung im politischen Umfeld, optimalerweise bereits erste Erfahrung in der pharmazeutischen Industrie
    • Sehr gute Kontakte in die Gesundheitspolitik (Spitzenverband, G-BA, Verbände)
    • Sehr gute Kommunikationsskills als Netzwerker und Influencer auf den politischen Bühnen Deutschlands
  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Development

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours or haematology. Study responsibility and line management of a small team.

    This is a great opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This growing Pharmaceutical company works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager with international trial management experience. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Development

    £70000 - £85000 per annum, Excellent package
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    MANAGER / SENIOR MANAGER, CLINICAL SCIENCE / CLINICAL DEVELOPMENT – FAST GROWING ATMP BIOTECH

    This is a great opportunity to join a fast-growing Biotech who do very exciting work in the advanced therapies space. They are doing work across multiple therapy areas at present. This is a superb time to join as they are advancing into phase II studies with their leading program but also other trials in early phase.

    The role is a senior clinical development scientist position, they are flexible on level and need an experienced clinical development or clinical science professional who has good experience of writing and developing clin dev plans and protocols, PhD preferred. It reports into the CMO. They need someone with Oncology experience, ideally from Pharma or Biotech.

    This is a full-time and permanent role. The company is based in the South East but they can offer remote working. They will offer a very good salary and it would depend on the level – around £70-85K depending on experience + bonus + benefits + shares.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details +44 207 220 6209 or APPLY NOW.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Medical Devices

    €75000 - €85000 per annum, Flexible Arbeitszeiten, Fahrtkostenzuschuss, Kindergartenzuschuss, Betr. Altersvorsorge, individuell leistungsgerechte Gehaltsentwicklung
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    Unser Kunde, ein mittelständisches Familienunternehmen im wunderschönen Norden Deutschlands sucht einen Manager in Sachen Sterilisation. Der Kunde ist ein etablierter und führender Anbieter von Medizinprodukten und führt seit mehr als 50 Jahren Innovationen in seinem Bereich an. Sein umfangreiches Produktportfolio ermöglicht Exporte in bereits mehr als 50 Ländern und ist somit international bekannt.

    Als Manager*in in der Sterilisation wäre dies ihr Aufgabengebiet:

    • Erstellung von Plänen und zugehörigen Berichten zur Biologischen Sicherheit gemäß ISO 10993-1
    • Koordination von Biokompatibilitätsprüfungen und Kommunikation mit externen Prüflaboren
    • Auswertung und Dokumentation von Prüfberichten
    • Planung, Durchführung und Überwachung von Sterilisationsvalidierungen (vorzugsweise Ethylenoxid sowie Gamma-Sterilisationsverfahren)
    • Kommunikation mit externen Sterilisationsdienstleistern sowie Koordination von entsprechenden Verfahrensabläufen
    • Bewertung von Validierungsberichten (insbesondere Verpackung und Sterilisation)
    • Screening, Bereitstellung und Umsetzung von relevanten Normenanforderungen unter Berücksichtigung des Stands der Technik
    • Erstellung relevanter Kapitel der Technischen Dokumentation gemäß Verordnung (EU) 2017/745
    • Kommunikation mit Lieferanten, Projektpartnern und Anwendern (national/ international)

    Für diese Stelle müssten Sie dieses Profil mitbringen:

    • Abgeschlossenes Studium (Chemie / Toxikologie, Biologie oder vergleichbar)
    • Fachkenntnis für Ethylenoxid sowie Gamma-Sterilisationsverfahren
    • Erfahrung in den Bereichen Biokompatibilität und Sterilisation
    • Kenntnisse von den entsprechenden einschlägigen Standards (ISO 10993, ISO 11135, ISO 11137, ISO 116076, REACH, RoHS)
    • Kenntnisse in den normativen und regulatorischen Anforderungen an Medizinprodukte (ISO 13485:2016, Richtlinie 93/42/EWG und Verordnung (EU) 2017/745
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Engagement und Leistungsbereitschaft
    • Bereitschaft zu abteilungsübergreifendem Arbeiten
    • Sehr gute Englischkenntnisse in Wort und Schrift

    Erkennen Sie sich mit Ihren Stärken wieder? Bewerben Sie sich gerne! Bei Rückfragen melden Sie sich gerne per Mail an fritz.koester@skillsalliance.com. Alternativ kann ich Ihnen in einem kurzen Telefonat auch mehr über diese Möglichkeit erzählen: +49 69 50 955 654

    Ich freue mich auf Ihre Mail / Ihren Anruf / Ihre Bewerbung!

  • Quality

    Competitive
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    Sind Sie offen für eine neue Herausforderung?

    Aktuell suchen wir für einen Kunden mit Sitz im Raum Düsselsdorf einen Mitarbeiter in der Qualitätskontrolle (m/w/d). Das moderne Unternehmen mit Fokus auf die Entwicklung von Arzneimitteltherapien besitzt eine familiäre Atmosphäre, hat weltweit ca. 20.000 Mitarbeiter und beitet viele Benefits für Arbeitnehmer.

    Das sind Ihre Aufgaben:

    • Unterstützung bei Produktreklamationen, sowie die entsprechende Dokumentation
    • Durchführung von Endotoxintests im Rahmen verschiedener Studien (Gel-Clog, PTS, kineisch chromogen)
    • Auführung von IQ-, OQ- und PQ-Prüfungen von Laborgeräten, sowie Pflege entsprechender Dokumente
    • Durchführung von Tests für Celsis- und LAL-Labore, inklusive Methodenentwicklungs- und Methodenvaliderungsstudien, Freigabe von Zubehör, usw.
    • Labortätigkeiten, die zur Isolierung, Anzucht und Erhaltung von Bakterienkulturen erforderlich sind
    • Durchführung und Verwaltung von Bioburden-Tests, Sterilitätstests, Membranfiltration und Reinigungsvalidierungen
    • Gewährleistung der Einhaltung einschlägiger gesetzlicher Vorschriften (cGMP, FDA, ISO), sowie abteilungsinterner Richtlinien (SOPs, Sicherheitsverfahren und Biosicherheitsprotokolle)
    • Mitwirken bei Inventuren von Laborverbrauchsmaterialien und Unterstützung bei der allgemeinen Instandhaltung des Labors, der Wartung von Geräten und der Planung von Gerätekalibrierungen
    • Mithilfe bei der stetigen Verbesserung von Unternehmensprozessen

    Das bringen Sie mit:

    • Natruwissenschaftliches Bachelorstudium in Mikrobiologie oder einer ähnlichen Ausrichtung
    • Mindestens 2 Jahre Berufserfahrung in einem mikrobiologischen Labor
    • Erfahrung mit LAL-Tests sind von Vorteil
    • Erfahrung im Arbeiten unter cGMP ist von Vorteil
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder telefonisch unter +496950988657.

  • HR and talent acquisition

    €120000 per annum, Gute Weiterentwicklungsmöglichkeiten, attraktives Gehaltspaket, Short und Long Term Incentives
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    Unser Kunde ist ein internationales Biotech Unternehmen in Hessen und mit mehr als 4000 Mitarbeitern in den unterschiedlichen Business Units ständig in Bewegung. Im Laufe der letzten Jahre hat unser Klient zahlreiche Auszeichnungen für seine unternehmerischen Leistungen, aber auch als Arbeitgeber erhalten. Sollten Sie ein solch agiles Unternehmen mit in die Zukunft begleiten wollen, dass suchen wir genau Sie als Direktor / Senior Manager HR (m/w/d).

    Ihre Aufgaben:

    • Sie sind Impulsgeber und Sparringspartner für die Geschäftsführung und die Führungskräfte in Ihrer Business Unit in allen HR-relevanten Themen
    • Weiterentwicklung strategischer HR Themen wie Führungskräfteentwicklung, Talent Management, Employer Branding, Mitarbeiterbindung und vieles mehr
    • Sie sind zentraler Ansprechpartner für strategische Themen wie Organisationsentwicklung, Change Management und Performance Management

    Ihr Anforderungsprofil:

    • Erfolgreich abgeschlossenes Studium der BWL, Psychologie oder Jura mit Schwerpunkt Arbeitsrecht
    • Sie verfügen über langjährige Berufs-/ sowie Führungserfahrung in crossfunktional organisierten Unternehmen
    • Sie verfügen über fundierte arbeitsrechtliche Kenntnisse und sind optimalerweise sicher im Umgang mit dem Tarifvertrag der chemischen Industrie
    • Sie bringen Erfahrungen im Bereich Changemanagement mit
    • Und verfügen über sehr gute Deutsch-/ und Englischkenntnisse in Wort und Schrift
  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

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    Great opportunity for an independent Senior Trial Manager (or AD) with strong Oncology experience. This is working in a very exciting and growing European based Biotech who have a great Immuno-Oncology pipeline and have had excellent feedback from the FDA. Need to be able to work in small Biotech environment and work autonomously. Basket studies and protocol writing experience would be a bonus. This is a great opportunity to work on innovative immuno-oncology studies, working in a team of around 35 highly experienced, high performing individuals. They have been very successful in securing over $170m in funding since their inception.

    This is a remote position working, requiring the candidate to be located in the East Coast, with an office location currently being set-up. It will report directly into the VP. You can expect a salary between $130-$180k USD depending on experience + bonus + benefits.

    If you are interested in this position, I would like to set up a call to discuss in further detail. Please let me know you earliest availability, attached to a up to date copy of your CV, ideally in word format.

    Thanks and I look forward to speaking with you.

  • CMC

    90000€ - 110000€
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    Regulatory Affairs Abteilung in Big Pharma sucht Zuwachs!

    Unser Kunde, einer der Top 10 Big Players in Pharma, sucht nach einem*r neuen Regulatory Affairs Manager*in an seinem Standort in Süddeutschland. Bringen Sie Erfahrung in Sachen Zulassung, Audits, CMC, PV und Drug Safety mit? Dann freuen wir uns auf Ihre Bewerbung!

    Weitere Aufgabengebiete sind unter anderem:

    • Aufgaben eines*r Informationsbeauftragten in Berücksichtigung von §74a des AMG
    • Durchführung von Audits
    • Aufbereitung und Pflege bereits ausgearbeiteter Zulassungen
    • Dossierpflege
    • Zusammenarbeit mit PV und Drug Safety
    • Hauptverantwortung für die Vereinbarung nationaler wissenschaftlicher Gutachten mit den zuständigen nationalen Behörden
    • Zusammenarbeit mit den europäischen Gruppen für RA und Unternehmen in regulatorischen Fragen
    • Enge Zusammenarbeit mit der Supply Chain, um etwaige Rückstände bei den auf dem Markt befindlichen Produkten zu erkennen

    Diese weiteren Qualitäten sollten Sie für diese Stelle mitbringen:

    • Erfolgreich abgeschlossenes Studium der Pharmazie oder einer anderen relevanten Naturwissenschaft
    • Langjährige Erfahrung in der Arzneimittelzulassung
    • Erfahrung in der Industrie
    • Qualifizierte*r Informationsbeauftragte*r nach §74a AMG
    • Sehr gutes Verständnis der nationalen und internationalen europäischen Arzneimittelregularien
    • Englische Sprache sehr gut in Wort und Schrift, Deutsche Sprache bestenfalls muttersprachlich oder sehr gut in Wort und Schrift

    Erkennen Sie sich in dieser Beschreibung wieder? Bewerben Sie sich!

  • CMC

    €60000 - €70000 per annum, Flexible Arbeitszeiten
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    Unser Kunde im schönen Bonn sucht nach Verstärkung in seinem Regulatory Affairs Team. Bei dem Unternehmen handelt es sich um einen Hersteller hochwertiger Arzneimittel aus eigener Forschung und Entwicklung.

    Das sollen Sie mitbringen:

    • 1-3 Jahre Erfahrung Regulatory Affairs für Arzneimittel
    • IT-Kenntnis in Datenbanken, Dokumentmanagementsystemen, sowie MS Office
    • Erfahrung im Umgang mit Dossier-Modul 3 (CMC)
    • Expertise mit nationalen Zulassungsverfahren sowie internationalem Life Cycle Management
    • Erfahrung in der Zusammenstellung von Zulassungsdossierts als eCTD Sequenzen
    • Fließende Englisch- und Deutschkenntnisse

    Das wären Ihre Aufgaben:

    • Erstellung und Prüfungs von Zulassungsdossiers
    • Durchführung von Zulassungsverfahren sowie Life Cycle Management inner- und außerhalb der EU
    • Korrespondenz mit Behörden sowie beantwortung von Mängelberichten
    • Erstellung, Prüfung und Freigabe von Packmitteln
    • Eingabe, Pflege und Überprüfung der Stammdaten in XEVMPD

    Ein Job genau für Sie? Bewerben Sie sich!

  • Medical Devices

    €60000 - €80000 per annum, Attraktive Sozialleistungen
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    Unser Kunde im schönen Unterfranken sucht nach Verstärkung in seinem Regulatory Affairs Team! Ein geeigneter Kandidat sollte in jedem Fall Erfahrung in der Arbeit mit aktiven und sterilen Medizinprodukten und/oder Software mitbringen. Lesen Sie unten weiter, ob die Stelle Ihr Interesse weckt und auf Ihre Kenntnisse passt:

    Ihr Tätigkeitsbereich

    • Verantwortung für internationale Registrierungs- und Re-Registrierungsprojekte für aktive und sterile Medizinprodukte
    • Planung und Durchführung von komplexen internationalen Zulassungsprojekten mit unseren lokalen Partnern / Distributoren
    • Mitwirkung an der Entwicklung von internationalen Zulassungsstrategien für aktive Medizinprodukte und Koordination mit dem F&E-Team
    • Mitwirkung an Änderungsanträgen zu zulassungsrelevanten Themen und Überprüfung normativer und regulatorischer Anforderungen (auch international)
    • Überprüfung interner Dokumente (z. B. Etikettierung, Werbematerialien, Schulungsunterlagen)
    • Kontinuierliche Unterstützung der Projektteams in regulatorischen Fragen, insbesondere auch während der Entwicklungsphase
    • Überprüfung von Änderungen im regulatorischen Umfeld und Mitteilung relevanter Änderungen an das Unternehmen, um eine kontinuierliche Einhaltung zu gewährleisten
    • Erstellung von Verfahren und internen Standards nach Bedarf (z. B. SOPs, Arbeitsanweisungen, Formulare und Checklisten)

    Ihr Profil

    • Abgeschlossenes Studium der im (Medizin-)technischen Bereich oder einer verwandten Disziplin
    • Mindestens 3-5 Jahre einschlägige Berufserfahrung
    • Erfahrung in der Zertifizierung und internationalen Registrierung von aktiven oder sterilen Medizinprodukten und in der Erstellung von Zulassungsdossiers
    • Erfahrung in der Entwicklung aktiver Medizinprodukte oder Software-Entwicklung
    • Kenntnisse der EU-, US- und weltweiten Vorschriften für Medizinprodukte
    • Kenntnisse der einschlägigen Normen und zugehörigen Prüfverfahren wie IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60601-1-6, IEC 60825, IEC 62304 sowie der entsprechenden Spezifikationen für sterile Medizinprodukte
    • Erfahrung in der Arbeit in multidisziplinären und internationalen Projektteams

    Soweit nach Ihrem Geschmack? Rückfragen können Sie gerne an Fritz Köster stellen:

    fritz.koester@skillsalliance.com | +49 69 50 955 654

    Wir freuen uns auf Ihre Bewerbung!