QA Operations Manager

Job Description

Job Description

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a QA Operations Manager.

• Contract
• Onsite

Required

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related technical discipline; advanced degree preferred.
• 8+ years of experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences manufacturing environment.
• Proven experience managing or overseeing QA Operations functions, including batch release, quality inspections, product complaints, NCR/CAPA management, and quality system processes.
• Strong knowledge of GMP requirements, quality systems, deviation management, CAPA processes, change control, and risk-based decision-making.
• Demonstrated leadership ability with experience managing cross-functional teams, mentoring quality professionals, supporting manufacturing operations, and serving as a quality partner during complex issue resolution and audits.

Responsibilities:

• Provide leadership and oversight across Quality Assurance Operations functions, including Batch Release, Quality Inspection, Product Complaints, Quality Operations, and Supplier Quality support to ensure effective quality system execution.
• Manage and support batch release activities, including serving as a qualified final batch release approver and providing oversight to ensure timely disposition of products in compliance with GMP requirements.
• Review, approve, and provide guidance on quality records including Nonconformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and exceptions, partnering with record owners to drive timely resolution and closure.
• Lead Change Review Board (CRB) activities and provide quality oversight, risk assessment, and decision-making support for operational changes and quality-related initiatives.
• Provide issue resolution, quality guidance, and cross-functional support to Operations teams while ensuring compliance with quality standards, regulatory expectations, and company procedures.