Manager, Quality Assurance Operations

Location: Madison, WI (On-Site)

About the Opportunity

Our client is a leading biotechnology manufacturing organization supporting the development and production of biologic therapies. This site specializes in biologics development and GMP manufacturing and is seeking a Manager, Quality Assurance Operations to lead quality oversight activities supporting manufacturing and quality operations.

This is a highly visible leadership role responsible for ensuring GMP compliance, supporting manufacturing operations, developing quality personnel, and serving as a key partner to internal stakeholders and external customers.

Key Responsibilities

• Lead, coach, and develop a team of Quality professionals
• Provide QA oversight for manufacturing operations, technology transfer activities, batch execution, and product disposition
• Ensure compliance with cGMP regulations and Quality Management System (QMS) requirements
• Support investigations, deviations, CAPAs, change controls, and continuous improvement initiatives
• Partner cross-functionally with Manufacturing, Quality Control, Technical Operations, and other site functions
• Serve as a key Quality representative during client interactions and audits
• Drive inspection readiness and support regulatory and customer audits
• Monitor quality metrics and identify opportunities to improve quality and operational performance
• Ensure adequate quality support for site operations and business objectives

Qualifications

• Bachelor's degree in a scientific discipline required
• 9+ years of GMP Quality experience, including QA Operations experience within a regulated pharmaceutical, biotechnology, or biologics manufacturing environment
• 4+ years of leadership experience managing or developing Quality teams
• Strong knowledge of cGMP regulations, FDA, EMA, and ICH requirements
• Experience supporting manufacturing operations and quality oversight within GMP environments
• Demonstrated expertise in investigations, deviations, CAPAs, change controls, and quality systems
• Strong communication skills with the ability to influence cross-functional teams and interact with customers
• Experience supporting biologics manufacturing strongly preferred

Preferred Background

• Biologics, vaccines, cell therapy, gene therapy, recombinant proteins, or related modalities
• Commercial manufacturing experience
• Regulatory inspection and audit experience
• Contract manufacturing (CDMO) experience preferred
• Proven track record of leading teams and driving continuous improvement initiatives