Associate Director QC Operations Lead
3 dagen 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.
Job DescriptionWe are seeking a highly motivated Associate Director to lead the QC Lab Operations and QC Support teams in our BioScience Park in Leiden, NL.
Key Responsibilities- Lead the QC Lab Operations and QC Support teams, providing guidance on compliance, processes, and prioritization.
- Define and implement the short-term and long-term strategy for testing, laboratory maintenance, equipment lifecycle, and sample management.
- Lead GMP readiness activities for internal laboratories and processes.
- Execute risk assessments as needed.
- Ensure compliance while keeping processes simple and efficient.
- Cross-functional collaboration to align strategy and processes.
- Write, review, or approve procedures, protocols, and reports.
- Support compliance-related topics, including deviations, CAPAs, and change controls.
- Support regulatory filings and health authority questions, including inspections.
The ideal candidate will have hands-on expertise in QC operations and a strong understanding of GMP regulations.
We offer a dynamic and challenging work environment with opportunities for growth and development.
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