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Regeneron

Director, Quality Assurance – Startup Biologics Facility

city of saratoga springs, NY

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Job description

Regeneron is building a Drug Substance facility in Saratoga Springs, NY, to begin operations in 2028, with a fully automated plant and a robust data integrity framework. The Director of Quality Assurance will lead startup quality systems, staffing and readiness for design review, commissioning and qualification.

You will define MES, DCS/SCADA, LIMS requirements, drive exception-based release, coordinate with IT and Engineering, and build a high‑performing QA team to ensure cGMP compliance across

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