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Regeneron Pharmaceuticals, Inc (USA)

Director, QA Validation & CSA Leadership

city of saratoga springs, NY

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Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Director of QA Validation to lead QA Validation, CSA, and Equipment Assurance for its Saratoga Springs, NY manufacturing site. The role covers validation lifecycle, risk-based qualification programs, and data integrity across GxP systems.

The candidate will drive CSA per FDA guidance and GAMP 5, oversee SDLC compliance, and collaborate with IT, automation, and manufacturing engineering to embed GxP in future-state manufacturing architecture.

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