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Director, GMP QA Operations
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role
Director of GMP QA Operations overseeing quality assurance for clinical and commercial products in an oncology-focused biopharma.
Responsibilities- lead QA activities across external manufacturing, including Drug Substance, Drug Product, and Finished Product
- review batch records, deviations, investigations, and batch disposition
- ensure GMP compliance, inspection readiness, and quality risk management
- support regulatory filings, inspections, and lifecycle activities
- provide leadership and mentorship to QA teams
- Bachelor's in a scientific/technical discipline
- 12+ years in GMP Quality, with 5+ years managerial experience
- extensive support of small molecule manufacturing, especially oral solid dosage forms
- strong knowledge of GMP regulations, batch release, and external partner oversight
- experience with commercial batch disposition, global supply, and post-approval lifecycle
GMP quality oversight for small molecule manufacturing, clinical to commercial phases, supporting external manufacturing networks, and regulatory compliance within oncology drug development.
Work Setupon-site in Redwood City, CA, with a salary range of $211,000-$264,000 USD.
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