Quality Assurance Operations Manager
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
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