- Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, and manufacturing.
- Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, and product complaints.
- Collaborate with CMC, Supply Chain, and Analytical Development to ensure compliance and on-time delivery.
- Manage Quality Agreements and provide proactive quality guidance in product development teams.
- Lead quality risk management activities to identify and mitigate GMP-related risks.
- Facilitate resolution of quality issues and coordinate communications with internal and external parties.
- Review CMC sections of regulatory filings and support regulatory authority inspections.
Quality AssuranceRisk Management