Quality Assurance Manager

Our client a fast-growing global biotechnology company that is expanding its U.S. operations. They are looking for a Quality Assurance Manager to establish and lead the site's Quality Management System (QMS).

This is a great opportunity to build quality systems from the ground up and support the production of cell culture media used in biologics, cell & gene therapy, and vaccine development.

• Lead the site's Quality Management System (QMS) and ensure GMP compliance.
• Manage document control, batch record review, deviations, CAPAs, change controls, and training.
• Support quality activities for cell culture and media manufacturing.
• Work closely with Manufacturing, R&D, and QC to maintain quality standards.
• Manage supplier quality, audits, and lot release activities.
• Build and lead the QA team while driving continuous improvement.

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field.
• 6+ years of QA experience in biologics, cell culture, biopharmaceuticals, or CDMO manufacturing.
• 2+ years of QA leadership or management experience.
• Strong knowledge of GMP, Quality Systems, batch documentation, deviations, CAPA, and change control.
• Experience supporting cell culture or GMP manufacturing operations.
• Strong communication and leadership skills.

• Startup or CDMO experience.
• Experience with cell culture media or upstream bioprocessing.
• Experience with supplier quality, audits, or eQMS.

• Lead the Quality function for a new U.S. manufacturing site.
• Help build quality systems from the ground up.
• Join a growing biotech company with strong career growth opportunities.
• Work on products supporting biologics and cell & gene therapies.