Director, QA Validation & CSA for GMP Digital Systems

Job description

Regeneron Pharmaceuticals, Inc in Saratoga Springs, NY seeks a Director of QA Validation to lead QA Validation, CSA, and Equipment Assurance for a highly automated biopharmaceutical facility. You will own the VMP and oversee qualification across GMP areas, MES, LIMS, DCS, and ERP integrations.

You will implement FDA/EMA guidance, maintain SDLC for GxP software, develop testing strategies, manage audits, ensure 21 CFR Part 11 compliance, and defend programs during inspections.

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Who can apply

Review the original listing for work authorization, qualifications and employer requirements.