Senior Manager, GMP and QMS Quality Operations

Job description

Role Overview & Key Functions: Summary: The Manager of GMP and QMS Quality Operations provides strategic and operational support within GMP Quality and Quality Systems. This is a dynamic role that will be responsible for leading training initiatives, providing vendors management support, driving process improvement, and partnering cross-functionally to support successful Quality operations. The Manager contributes to the continuous evolution of the CSV program, training management program, and strategy for improvement of cross-functional Quality Compliance. Key Responsibilities: Reporting to the Executive Director, GMP and QMS Quality Assurance GMP and QMS Quality Operational Support - When applicable, support day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches - Monitors operational activities and assesses continuous improvement within the QA operations - Serve as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances - Facilitate root cause / A3 problem solving...