Quality Assurance Manager

🇺🇸 Irvine, CA 🕑 Full-Time 💰 $119K - $231K 💻 Quality Assurance 🗓️ July 10th, 2026

Clari Six Sigma Sigma

Edtech.com's Summary

University of California, Irvine is hiring a Quality Assurance Manager to lead the GxP quality assurance functions at its new GMP cellular therapy facility. The role involves directing staff, managing quality and compliance programs, and ensuring adherence to FDA regulations and industry standards within the clinical product manufacturing environment.

Highlights

Provide strategic leadership for GxP functions in a cGMP facility specializing in cell therapy and viral vector manufacturing.
Manage quality assurance programs including deviation and CAPA systems, change management, and vendor quality management.
Ensure compliance with FDA regulations and industry best practices related to GMP, GLP, and clinical product release.
Require expertise in quality and process improvement methodologies, statistical analysis, and database management.
Must have knowledge of Six Sigma, DMAIC, Quality Risk Management tools (e.g., FMEA, RCA), and regulatory requirements including 21CFR parts related to pharmaceuticals.
Bachelor's degree in Nursing or relevant healthcare field with 5+ years in quality assurance and 2+ years in management.
Experience working with contract manufacturing/testing facilities and familiarity with Qualified Persons.
Technical proficiency in medical terminology, human anatomy, chemistry, molecular biology, and computer software (word processing, data management, spreadsheets).
Salary range from USD $119,400.00 to $230,800.00 per year.
Supports clinical trials of cell therapeutics including stem cells, bone marrow transplantation, and CAR T-cell therapies.