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Quality Cluster Lead Computerized Systems
Santen
Amsterdam · On-siteLead (10+ years)Full-timePosted 29 days ago
About the job
What you'll do
The Quality Cluster Lead will manage the EMEA Computerized System Quality Team and ensure all IT infrastructure, SAP systems, and electronic QMS platforms remain in a compliant and inspection-ready state. They will drive quality governance, lead validation activities, and act as the primary interface for compliance matters across the region.
What they're looking for
Candidates must have over 10 years of industrial experience, including at least 5 years in Computerized System Quality Review and Validation within the pharmaceutical or medical device sector. A bachelor's degree in a relevant scientific or engineering discipline is required, along with strong knowledge of GAMP 5, GMP Annex 11, and 21 CFR Part 11.
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