QA Operations Manager

Responsibilities

• Provide leadership and oversight across Quality Assurance Operations functions, including Batch Release, Quality Inspection, Product Complaints, Quality Operations, and Supplier Quality support.
• Manage and support batch release activities, including serving as a qualified final batch release approver and ensuring timely product disposition in compliance with GMP requirements.
• Review, approve, and provide guidance on quality records, including Nonconformance Reports, CAPAs, and exceptions.
• Partner with record owners and cross-functional teams to drive timely investigation, resolution, and closure of quality events.
• Lead Change Review Board activities and provide quality oversight, risk assessment, and decision-making support for operational changes.
• Provide quality guidance and issue-resolution support to Operations teams.
• Ensure compliance with quality standards, regulatory expectations, GMP requirements, and established procedures.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical discipline; advanced degree preferred.
• 8+ years of Quality Assurance experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences manufacturing environment.
• Experience managing or overseeing QA Operations functions, including batch release, quality inspections, product complaints, NCRs, CAPAs, and quality systems.
• Strong knowledge of GMP requirements, deviation management, CAPA processes, change control, and risk-based decision-making.
• Demonstrated leadership experience managing cross-functional teams, mentoring quality professionals, supporting manufacturing operations, and participating in audits.