Senior Director of Quality Control Operations
4 weken geleden
Galapagos is a dynamic and fast-growing biotech company dedicated to making a lasting positive contribution to society through the discovery of innovative therapies for diseases with large unmet medical need.
The company's ambition is to become a leading global biopharmaceutical company, focused on the discovery, development, and commercialization of innovative medicines to improve patients' lives.
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.
As part of this expansion, we are looking for a highly motivated Associate Director to lead the QC Lab Operations and QC Support teams in our BioScience Park in Leiden/NL.
The Associate Director QC Operations would be responsible for leading the QC Lab Operations and QC Support teams while being responsible for providing direction on the strategy and the different processes for which each team is responsible.
The QC Lab Operations team is responsible for testing drug product, characterization, product monitoring, immune monitoring, and incoming goods samples. The QC Support team is responsible for the lifecycle of equipment, sample management, and maintaining the laboratories.
The ideal candidate will have hands-on expertise to provide guidance on compliance, prioritization, and process implementation. They will define and implement the short-term and long-term strategy for the processes related to testing, laboratory maintenance, equipment lifecycle, and sample management.
The Associate Director will lead the activities related to GMP readiness of the internal laboratories and processes, execute risk assessments, and ensure that the processes designed and implemented within the teams are compliant, simple, and efficient.
They will collaborate cross-functionally to ensure that strategy and processes are aligned and communicated, write, review, or approve procedures, protocols, and reports, and support compliance-related topics, regulatory filings, and health authority questions, including inspections.
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