The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility 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. In this role, you will direct departmental staff while executing the functional mission and vision. You will be responsible for establishing strategic partnerships and implementing risk-based quality programs for UC Irvine GMP operations. Furthermore, you will oversee the deviation and CAPA systems, change management processes, and quality management of vendors and service providers. You are responsible for ensuring comprehensive compliance with FDA and all applicable GxP regulations and industry best practices.

What It Takes to be Successful

Required:

• Demonstrated management skills, with progressive expertise in quality and process improvement methodologies, statistical analysis, and data base 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 Occupational Safety and Health Act (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. Must be able to 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 to remain flexible with a variety of changing demands
• Ability to manage several projects or tasks simultaneously and to exercise appropriate judgment when prioritizing projects of 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 the cellular therapy production
• Experience in reviewing GMP/GLP related documents (SOP's, 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 other relevant healthcare profession, or a combination of comparable clinical education and / or experience.
• 5 years of experience in quality assurance, preferably within a GMP environment
• 2+ years management experience

Preferred:

• In depth knowledge in 21CFR Part 11 , 21CFR 210, 21CFR211, 21CFR600 and 21CFR610.

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 benefits 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:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following 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: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization