Senior QA Specialist for Cell

4 weken geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd

We are Galapagos, a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

We're in the business of changing lives. Our quest to discover and develop life-improving medicines drives us to pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class.

For our Cell & Gene Therapy organization in Leiden/NL, we are seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist).

Scope of the role:

To support our QA team in setting up, promoting and maintaining the QA model in our dynamic business environment. Our QA team plays a crucial role in building our QA model for our expanding organization while working closely together with the Point-of-Care manufacturing partners.

At Galapagos, we believe in the power of collaboration to achieve our ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.

As our QA PoC and Central Site coordinator, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.

Responsibilities:

  • Manage QM attributes for PoC and Central Site activities: Deviations, CAPAs, Change Controls and Complaints
  • QA batch record review
  • Support materials release and support batch release process
  • Support equipment management at our PoC locations
  • Provide QA support to the materials kitting process

  • Senior QA Specialist: Cell

    4 weken geleden


    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are seeking a highly motivated QA Specialist to join our Cell & Gene Therapy organization in Leiden, NL. As a QA Specialist, you will play a crucial role in setting up, promoting and maintaining the QA model in our dynamic business environment.The QA team is a team of 11 and plays a crucial role in building our QA model for our expanding organization...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. Our Cell & Gene Therapy organization in Leiden/NL is seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist) to support our QA team in setting up, promoting and...

  • Biotech QA Specialist

    5 dagen geleden


    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic growing biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We pioneer for patients, discovering and developing life-improving medicines that change lives. We need thought leaders and rapid thinkers who are entrepreneurs at heart and status quo-fighters. Collaborative innovators and...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are seeking a highly motivated and experienced QA Point of Care and Central Site Coordinator to join our dynamic team at Galapagos, a leading Biotech company in Europe and the US.Located in Leiden, Netherlands, this role is a key part of our Cell & Gene Therapy organization, where we develop life-improving medicines and pioneer new treatments.The ideal...

  • QA Program Lead PoC

    4 weken geleden


    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...


  • Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

    Oxford Global Resources is a leading biotechnology company at the forefront of developing innovative CAR-T immune therapies for cancer treatment. Our cutting-edge technologies, such as point-of-care cell therapy production models, enable us to provide efficient and effective treatment options.**Job Summary:**We are seeking an experienced Senior Operator/SME...

  • Senior Consultant

    3 weken geleden


    Leiden, Zuid-Holland, Nederland ProPharma Group Voltijd

    We are seeking a highly experienced Senior Consultant - Qualified Person to join our team at ProPharma Group. This role will involve working with clients in the Cell & Gene therapy (ATMP) area, providing expert advice and guidance on quality assurance and regulatory matters.Key Responsibilities:Provide independent consultation to clients and project...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as QA Program Lead PoCGalapagos is a leading biotech company with a focus on changing lives through innovative medicines. We are seeking a highly motivated QA Program Lead PoC to join our Cell & Gene Therapy organization in Leiden, NL.About the RoleYou will be responsible for supporting our QA point-of-care operations team in setting up,...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are seeking a highly motivated Senior Quality Assurance Program Lead to support our QA point-of-care operations team in setting up, promoting and maintaining the QA model in our dynamic business environment.Our QA team plays a crucial role in building our QA model for our expanding organization while working closely together with the Point-of-Care...

  • Senior Process Engineer

    4 weken geleden


    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...

  • Senior Process Engineer

    3 weken geleden


    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos, a pioneering biotech company with offices across Europe and the US, headquartered in Mechelen, Belgium, is looking for a highly skilled professional to drive continuous improvement initiatives in its cell therapy manufacturing organization.The ideal candidate will have a passion for excellence, a track record of process improvement success, and a...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos is a dynamic and fast-growing Biotech company that is changing lives through the discovery of innovative therapies for diseases with large unmet medical need.We are expanding our pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined...


  • Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    Transforming the Future of MedicineBristol Myers Squibb, a leading pharmaceutical company, is seeking an experienced Capital Projects Director to lead the site capital project processes for our new cell therapy facility in The Netherlands. This is an exciting opportunity to shape the strategy vision of our Cell Therapy Facility and play a critical role in...


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    At Galapagos, a pioneering Biotech company with operations across Europe and in the US, headquartered in Mechelen, Belgium, we are committed to changing lives through innovative medicines.We need collaborative innovators and perseverant idealists who can drive our Point-of-Care manufacturing operations forward. As a highly motivated QA Program Lead PoC...


  • Leiden, Zuid-Holland, Nederland ProPharma Group Voltijd

    ProPharma Group is seeking a highly experienced Cell and Gene Therapy Regulatory Expert to join our team as a Senior Consultant.Key Responsibilities:Act as a key Subject Matter Expert in assigned areas of quality assurance and regulatory/GxP.Provide Independent consultation with clients and project leadership to a range of challenging and fascinating...


  • Leiden, Zuid-Holland, Nederland ProPharma Group Voltijd

    At ProPharma Group, we are seeking a seasoned Cell and Gene Therapy Specialist to join our team as a Regulatory Compliance Expert. This is an exciting opportunity for a highly skilled professional to spearhead challenging projects across the CQA space and contribute to the success of our clients in the EU.


  • Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    {"​​At Galapagos, we’re committed to changing lives through innovative biotech solutions. As a highly motivated Cell & Gene Therapy organization in Leiden/NL, we’re seeking a visionary (Senior) Process Engineer to join the Point-of-Care Manufacturing team (PoC)\. This team provides technical-operational expertise to the GMP operations at...


  • Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

    Job Title: Senior Quality Assurance SpecialistJob Description:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Oxford Global Resources. As a Senior Quality Assurance Specialist, you will play a crucial role in ensuring the highest standards of quality in our laboratory operations.Responsibilities:Provide expert Quality...