Senior Director of Quality Control Operations
3 dagen geleden
Galapagos is a dynamic and fast-growing biotech company that is changing lives through the discovery of innovative therapies for diseases with large unmet medical need.
The company's mission is to make a lasting positive contribution to society by developing a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms.
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 a highly motivated Associate Director, you will lead the QC Lab Operations and QC Support teams, providing direction on the strategy and processes for which each team is responsible.
Key responsibilities include leading the activities related to GMP readiness of the internal laboratories and processes, executing risk assessments, and ensuring that processes are compliant while keeping simple and efficient.
You will collaborate cross-functionally to ensure that strategy and processes are aligned and communicated, and support compliance-related topics, regulatory filings, and health authority questions, including inspections.
Galapagos is a company that is passionate about making a difference in people's lives, and we are looking for individuals who share this passion and are committed to excellence.
Join us in our mission to develop innovative medicines that improve patients' lives.
Key Responsibilities:
- Lead the QC Lab Operations and QC Support teams
- Define and implement the short-term and long-term strategy for the processes related to testing, maintenance of the laboratories, equipment lifecycle, and sample management
- Lead the activities related to GMP readiness of the internal laboratories and processes
- Lead and execute risk assessments, as needed
- Ensure that processes are compliant while keeping simple and efficient
- Collaborate cross-functionally to ensure that strategy and processes are aligned and communicated
- Support compliance-related topics, regulatory filings, and health authority questions, including inspections
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