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BioSpace

Director of QA — Drug Substance Manufacturing (Automated Plant)

city of saratoga springs, NY

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Job description

Regeneron is seeking a Director of Quality Assurance to lead the startup and long‑term operations of the Saratoga Springs Drug Substance facility, a greenfield biologics site opening in 2028. You will build QA systems, workforce and readiness for design review, commissioning and process validation.

You will define automation and data integrity requirements (MES, DCS/SCADA, LIMS), partner with Automation, Engineering and IT to enable review‑by‑exception batch disposition, and lead a highly

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