Head of Quality Assurance Cell Therapy
2 weken geleden
We 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 Assurance Cell Therapy to join our team. As a key member of our organization, you will play a crucial role in shaping our 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 Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
- Define and implement effective oversight of quality control processes, ensuring 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.
To be successful in this role, you will need to have a strong background in quality assurance, with experience in decentralized manufacturing and ATMP regulations. You will also need to have excellent leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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Head of Quality Assurance Cell Therapy
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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...
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