Head of Quality Assurance Cell Therapy
5 dagen geleden
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 thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The 'make-it-happener'.
We are looking for a Head of Quality Assurance Cell Therapy
Scope of the job
With our innovative CAR-T cell therapy, which is a decentralized manufacturing model at the point-of-care, we passionately work on the potential for cancer patients to offer efficient, 7-day time to treatment avoiding complex logistics and resulting in potential better patient outcomes and broader access. As our Head of Quality Assurance Cell Therapy, you will play a key role in shaping strategic directions in close collaboration with QC, Manufacturing, Supply Chain and other internal and external stakeholders as we are rapidly scaling up our activities in Europe and the US. An exciting opportunity with a strong focus on ATMP regulations.
Your role
- Develop and Implement Quality Systems related to a decentralized manufacturing ('point of care manufacturing'): Design and implement robust quality systems to ensure compliance with regulatory requirements, industry standards, and company policies across all stages of cell and gene therapy product development, manufacturing, and distribution.
- Regulatory Compliance: Stay abreast of relevant regulatory guidelines and ensure adherence to applicable regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), specifically considering the ATMP regulations. Collaborate with regulatory affairs teams to support regulatory submissions and inspections.
- Quality Assurance Oversight: Provide strategic leadership and oversight to the quality assurance function, including managing quality assurance activities, conducting risk assessments, implementing quality improvement initiatives, and establishing appropriate metrics to monitor performance and drive continuous improvement.
- Quality Control Oversight: Define and implement effective oversight of quality control processes to ensure the accurate and reliable testing and release of cell and gene therapy products, including raw materials, intermediates, and final drug products. Develop and maintain strong relationships with external testing laboratories and contract manufacturing organizations (CMOs).
- Risk Management: Lead the development and implementation of risk management strategies to identify, assess, and mitigate quality risks associated with cell and gene therapy products. Apply risk-based approaches to decision-making and develop appropriate risk mitigation plans.
- Training and Development: 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. Foster a culture of quality and compliance throughout the organization.
- Audit and Inspection Readiness: 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.
- Collaboration and Stakeholder Management: Collaborate effectively with cross-functional teams, including technical operations, research and development, quality control, clinical operations, regulatory affairs, and commercial teams. Ensure strong relationships with external stakeholders, including regulatory authorities, CMOs, and external auditors.
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