Quality Assurance Manager

Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation, and its anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second‑largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. Facility Overview The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). The facility will enable clinical trials of cell therapeutics, including stem cell populations, bone marrow transplantation, and Chimeric Antigen Receptor (CAR) T‑cells. It includes a seven‑room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory. Your Role on the Team As the Senior Manager of Quality Assurance, you will provide strategic leadership for the GxP functions at the UC Irvine GMP facility. You will direct departmental staff while executing the functional mission and vision, establish strategic partnerships, implement risk‑based quality programs, and oversee deviation, CAPA, change management, vendor and service provider quality management. You will ensure comprehensive compliance with FDA and all applicable GxP regulations and industry best practices. Required Demonstrated management skills, with progressive expertise in quality and process improvement methodologies, statistical analysis, and database management. Proven ability to organize, manage multiple priorities, meet deadlines, and assign work efficiently. Strong critical‑thinking and problem‑solving skills, with the ability to quickly identify problems and implement solutions. Demonstrated knowledge of relevant regulatory requirements, as well as related legislative, accreditation, licensing, and compliance environments. Working knowledge of cGMPs, GLPs, and associated regulatory requirements for the manufacture, testing, and release of clinical products. In‑depth knowledge of QA principles, concepts, industry practices, and standards. Experience in the use of Six Sigma, DMAIC methodology, and/or quality improvement statistical tools. Hands‑on experience in Quality Risk Management principles and tools (e.g., FMEA, RCA). Adherence to excellent customer service principles. Must possess technical vocabulary to meet facility needs. Ability to listen, collect information, and give instructions to support, clarify, or resolve problems. Knowledge of personal computer, word processing, data management, and spreadsheet software. Knowledge of standard precautions and biosafety. Knowledge of OSHA and laboratory safety regulations. Must possess knowledge of medical terminology, basic human anatomy, chemistry, biology, and molecular biology and technical knowledge to complete assigned tasks. Must be able to write clear technical reports in the scientific format and maintain logs and documentation in the same manner. Maintains appropriate interdepartmental communication. Tact and diplomacy skills to meet the needs of a highly interactive position. Ability to work well under pressure to meet commitments and remain flexible with a variety of changing demands. Ability to manage several projects or tasks simultaneously and to exercise appropriate judgment when prioritizing projects or assignments. Ability to work as a member of a team and to assist colleagues as needed. Ability to function and work in a diverse work environment. Knowledge of federal and state legislation and regulatory requirements pertaining to cellular‑therapy production. Experience in reviewing GMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.). Experience working with contract manufacturing and testing facilities; experience with interacting with Qualified Persons. Bachelor’s degree in Nursing or another relevant healthcare profession, or a combination of comparable clinical education and/or experience. Five years of experience in quality assurance, preferably within a GMP environment. Two or more years of management experience. Preferred In‑depth knowledge of 21CFR Part 11, 21CFR 210, 21CFR 211, 21CFR 600 and 21CFR 610. Total Rewards In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits. Conditions of Employment Background Check and Live Scan Employment Misconduct Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug‑Free Environment Misconduct Disclosure Requirement: Final candidate must disclose any mandatory disciplinary proceedings within the last seven years. California Child Abuse and Neglect Reporting Act E‑Verify Pre‑Placement Health Evaluation Closing Statement The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti‑Discrimination Policy. We are committed to attracting and retaining a diverse workforce and honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, contact Human Resources at (949) 824‑0500 or View email address on click.appcast.io. Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization. #J-18808-Ljbffr