What are the responsibilities and job description for the Quality Assurance Manager position at ViewIn Advisory?
About the Company
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.
What You'll Do
- 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.
What We're Looking For
- 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.
Nice to Have
- Startup or CDMO experience.
- Experience with cell culture media or upstream bioprocessing.
- Experience with supplier quality, audits, or eQMS.
Why Join?
- 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.