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Associate Director QC Operations Lead
2 maanden geleden
We are seeking a highly motivated and experienced Associate Director to lead our QC Lab Operations and QC Support teams at Galapagos, a dynamic and fast-growing Biotech company.
About the RoleThe Associate Director QC Operations will be responsible for providing strategic direction and leadership to the QC Lab Operations and QC Support teams, ensuring compliance with regulatory requirements and maintaining a high level of quality in our laboratories.
Key Responsibilities- Lead the QC Lab Operations and QC Support teams, providing guidance on compliance and prioritization
- Define and implement short-term and long-term strategies for testing, laboratory maintenance, equipment lifecycle, and sample management
- Lead GMP readiness activities for internal laboratories and processes
- Conduct risk assessments and ensure compliance with regulatory requirements
- Collaborate cross-functionally to ensure strategy and processes are aligned and communicated
- Write, review, and approve procedures, protocols, and reports
- Support compliance-related topics, including deviations, CAPAs, and change controls
- Support regulatory filings and health authority questions, including inspections
Galapagos is a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to improve patients' lives. We are committed to making a lasting positive contribution to society through the discovery of novel therapies for diseases with large unmet medical need.
We are now entering an exciting new chapter to expand and diversify our pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies.
CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access.