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An established industry player in pharmaceutical manufacturing is seeking a Quality Assurance Manager to lead QA activities and ensure compliance in a dynamic sterile manufacturing environment. This role offers the chance to shape a robust quality function, interfacing with production and regulatory teams. The ideal candidate will have a strong background in GMP compliance and leadership experience in aseptic manufacturing. Join a forward-thinking company that values operational excellence and offers relocation assistance for the right candidate.
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Manufacturing QA Manager | CDMO Fill/Finish
Metric Bio are partnered with a market-leading, fast-growing US-based CDMO focused on aseptic and sterile manufacturing as they search for a Quality Assurance Manager.
This role is based on-site in the Southwest USA. Relocation assistance is available!
This individual will serve as the QA lead for all manufacturing activities, providing GMP oversight across in-process inspections, batch record review, and deviation resolution. They will act as the site’s quality subject matter expert, interfacing with production, regulatory, and validation teams to ensure compliance and operational excellence.
Key Responsibilities:
• Lead daily QA activities across manufacturing operations, including batch record review and product release.
• Serve as SME for GMP compliance, product inspection, and batch investigations.
• Manage QA staff and drive training, development, and performance reviews.
• Support validation closure, change control, and quality system compliance.
• Represent QA during audits, inspections, and cross-functional initiatives.
Requirements:
• Bachelor’s in Science, Chemistry, Biology, or related field.
• 5+ years in aseptic/sterile pharmaceutical manufacturing QA.
• 2+ years of QA leadership experience in a GMP environment.
• Strong understanding of quality systems, regulatory guidelines, and manufacturing operations.
• Experience with third-party contract manufacturing (CDMOs) strongly preferred.
This is a key leadership opportunity to shape a robust manufacturing quality function within a dynamic sterile manufacturing CDMO environment.
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