• Supervise and lead a team of QA personnel, including coaching, mentoring, and conducting performance evaluations.
• Provide QA on-the-floor (QAOTF) support for manufacturing operations and ensure compliance with cGMP requirements.
• Review and approve GMP documentation including batch records, deviations, change controls, CAPAs, and SOPs.
• Support and lead investigations, including deviations, OOS events, and corrective actions.
• Act as QA representative during internal and external audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, MSAT, Facilities, and Quality Systems teams.
• Perform QA walkthroughs and provide real-time oversight of production activities to identify and resolve quality issues.
• Ensure training compliance and development of QA staff in alignment with site and regulatory requirements.
• Support gowning requirements (Level 3 / Grade B) and cleanroom activities as needed.