- Provide GMP quality oversight of CMO/CDMO manufacturing and testing activities for assigned products.
- Review and approve batch records, deviations, CAPAs, and change controls related to GMP manufacturing.
- Support product disposition and release activities in collaboration with Quality Control and Regulatory.
- Lead or support internal and external GMP audits, including CMO/vendor qualification audits.
- Manage quality agreements and ongoing quality oversight of external manufacturing partners.
- Support inspection readiness and represent Quality during health authority inspections.
- Perform other duties and responsibilities as assigned.
Quality Assurance