Leads quality assurance function for one or more manufacturing sites. Responsible for GMP compliance across all manufacturing and support functions. Manages preparation and submission of responses to regulatory authority observations. Oversees change control, deviation management, and CAPA closure programs. Reviews and approves all critical quality documents and batch release decisions. Leads regulatory inspections including US-FDA, EU-GMP, and WHO pre-qualification. Develops and implements quality improvement initiatives across the site. Manages vendor qualification programs and third-party manufacturing compliance. Ensures validation lifecycle management for equipment, processes, and cleaning. Prepares site quality metrics and KPIs for management review meetings. Manages annual product quality review and product quality management systems. Mentors QA executives and builds team capability in quality management. Stays current with regulatory guidances, warning letters, and inspection trends.