Head of Quality Assurance Cell Therapy

1 week geleden

Leiden, Zuid-Holland, Nederland Galapagos Voltijd

About Galapagos

We are a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to change lives by discovering and developing life-improving medicines.

Job Title: Head of Quality Assurance Cell Therapy

We are seeking a highly experienced and skilled professional to lead our Quality Assurance team for Cell Therapy. As Head of Quality Assurance Cell Therapy, you will play a key role in shaping strategic directions and ensuring compliance with regulatory requirements, industry standards, and company policies.

Key Responsibilities:

  • Develop and implement quality systems for decentralized manufacturing, ensuring compliance with regulatory requirements and industry standards.
  • Provide strategic leadership and oversight to the quality assurance function, including managing quality assurance activities, conducting risk assessments, and implementing quality improvement initiatives.
  • Collaborate with regulatory affairs teams to support regulatory submissions and inspections, ensuring adherence to applicable regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
  • Define and implement effective oversight of quality control processes to ensure the accurate and reliable testing and release of cell and gene therapy products.
  • Lead the development and implementation of risk management strategies to identify, assess, and mitigate quality risks associated with cell and gene therapy products.
  • Provide guidance and training to quality and cross-functional teams regarding quality principles, compliance requirements, and best practices in cell and gene therapy and ATMP.
  • Prepare the organization for regulatory audits and inspections, including conducting internal audits, overseeing corrective and preventive actions (CAPAs), and addressing any findings or observations identified during inspections.

Requirements:

  • Proven experience in quality assurance and regulatory compliance in the biotech or pharmaceutical industry.
  • Strong knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), as well as ATMP regulations.
  • Excellent leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.

What We Offer:

  • A dynamic and growing company with a strong focus on innovation and quality.
  • A competitive salary and benefits package.
  • The opportunity to work on cutting-edge projects and contribute to the development of life-improving medicines.

How to Apply:

Please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you

  • Head of Quality Assurance Cell Therapy

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    {"title": "Head of Quality Assurance Cell Therapy", "content": "At Galapagos, we are pioneers in the field of cell and gene therapy, and we are seeking a highly skilled and experienced professional to lead our quality assurance efforts in this exciting area.As our Head of Quality Assurance Cell Therapy, you will play a critical role in shaping the strategic...

  • Head of Quality Assurance Cell Therapy

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as a Head of Quality Assurance Cell TherapyWe 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 innovative CAR-T cell therapy is a decentralized manufacturing model at the point-of-care, offering efficient, 7-day time to...

  • Head of Quality Assurance Cell Therapy

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as a Head of Quality Assurance Cell TherapyWe are Galapagos, a dynamic and growing Biotech company with a strong presence in Europe and the US, headquartered in Mechelen, Belgium. Our mission is to change lives by discovering and developing life-improving medicines.About the RoleWe are seeking a highly skilled and experienced Head of Quality...

  • Head of Quality Assurance Cell Therapy

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as a Head of Quality Assurance Cell TherapyWe 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. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we...

  • Head of Quality Assurance Cell Therapy

    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'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...

  • Head of Quality Assurance Cell Therapy

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as a Head of Quality Assurance Cell TherapyWe 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. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we...

  • Head of Quality Assurance Cell Therapy

    2 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'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 Consultant

    2 dagen 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...

  • Quality Assurance Manager

    2 weken geleden

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

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a company that pushes the boundaries of what's possible in the field of biotechnology. We're not just looking for talented individuals to join our team; we're seeking passionate professionals who share our vision of transforming patients' lives through science.About the RoleWe're seeking a...

  • Site IT Lead, Cell Therapy

    2 maanden geleden

    Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

    About the RoleThe Director, IT Site Lead position plays a critical role in managing all corporate & locally supported infrastructure and software at the Cell Therapy manufacturing site. IT is committed to achieving excellence as measured (in part) by their effectiveness in supporting business functions and related business processes across the company.This...

  • Biotechnology Quality Assurance Specialist

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

    Job Title: Biotechnology Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Biotechnology Quality Assurance Specialist to join our team at Oxford Global Resources. As a key member of our Manufacturing team, you will play a crucial role in ensuring the quality and efficiency of our cell therapy products.Responsibilities:Improve GMP...

  • Scientist Cell Therapy Specialist

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Leiden Bio Science Park Voltijd

    Our OfferWe are looking for a talented Cell Therapy Scientist to join our team at Leiden Bio Science Park.As a Cell Therapy Scientist, you will be part of a dynamic and inspiring working environment with a flat organization and short lines. You will have the opportunity to work on exciting projects and contribute to the development of new cell...

  • Quality Assurance Specialist

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

    Job Title: QA SpecialistAre you passionate about ensuring the highest quality in biotechnology products? We are seeking a highly skilled QA Specialist to join our team at Oxford Global Resources.About the Role:As a QA Specialist, you will play a critical role in maintaining the quality and integrity of our cell therapy products. Your primary responsibility...

  • Quality Assurance Program Lead for Cell and Gene Therapy

    3 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'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...

  • CAR-T Cell Therapy Manufacturing Expert

    2 maanden geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos' MissionWe are a dynamic and fast-growing biotechnology company dedicated to making a lasting positive contribution to society through the discovery of innovative therapies for diseases with large unmet medical need.Our historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led...

  • Biotechnology Quality Assurance Specialist

    1 maand geleden

    Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

    About the RoleWe are seeking a highly skilled GMP Specialist to join our Manufacturing team in Leiden. As a key member of our team, you will play a crucial role in ensuring quality and efficiency in our cell therapy production process.Key ResponsibilitiesDevelop and implement GMP awareness programs to enhance quality culture within the organizationSupervise...

  • Materials Quality Specialist

    1 week geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    We are Galapagos, a dynamic and growing Biotech company with a presence across Europe and the US, headquartered in Mechelen, Belgium.We're on a mission to change lives by discovering and developing life-improving medicines. Our Cell Therapy organization in Leiden, NL, is seeking a highly skilled Materials Quality Consultant to support our transition from an...

  • Quality Assurance Specialist

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos: Pioneering for PatientsWe're a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to discover and develop life-improving medicines, and we're seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist) to join our Cell & Gene Therapy organization in...

  • Quality Assurance Specialist

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Galapagos: Pioneering for PatientsWe're a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to discover and develop life-improving medicines, and we're seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist) to join our Cell & Gene Therapy organization in...

  • Quality Assurance Program Lead

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Galapagos Voltijd

    Join Our Team as a QA Program Lead PoCWe are Galapagos, a dynamic and growing Biotech company with a strong presence in Europe and the US, headquartered in Mechelen, Belgium.We're on a mission to change lives by discovering and developing life-improving medicines. Our team is passionate about pioneering for patients and pushing the boundaries of what's...