Provide oversight and continuous improvement for all elements applicable to 21 CFR parts 820, 210, 211: CAPA program including investigations and non-conformances, Design & Change Control, Complaint Handling including all applicable post-market surveillance activities, Product Quality Reviews / Annual Product Reviews, Supplier Quality Management, Internal Audit, Training, Data Integrity, Documentation Management, Risk Management. Ensure scientifically sound testing programs for raw materials/components/finished goods, stability programs, environmental monitoring & utilities.