- Ensure manufacturing operations at CMOs and partners comply with regulatory requirements and internal quality standards.
- Lead clinical lot disposition and batch record review to support release and QP certification activities.
- Oversee GMP Quality Systems including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations.
- Conduct cGMP audits of vendors, CMOs, contract testing labs, and logistics providers, and manage Quality Agreements.
- Provide quality and technical input for cross-functional project teams and review documentation like protocols and SOPs.
- Partner with CMC, Supply Chain, and Regulatory Affairs to manage product quality risks and mitigation plans.
- Lead regulatory inspection preparation and readiness activities.
- Support the review of CMC sections for regulatory submissions like INDs and IMPDs.
Risk Management