This hands-on leadership role includes direct responsibility for GMP batch release and disposition, manufacturing compliance and quality oversight, external vendor compliance including quality agreements & audits, deviation, change control, risk assessment, investigation and CAPA management, oversight of validation activities, and regulatory inspection readiness. Lead and contribute to GMP Quality investigations, deviations, CAPAs, change controls, risk assessments, out-of-specification investigations, and product disposition activities, ensuring appropriate documentation, resolution, and effectiveness.