Quality Assurance Manager

University of California, Irvine•Irvine, CA

7d•Onsite

About The Position

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 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. To learn more about UC Irvine, visit www.uci.edu. 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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

Provide strategic leadership for the GxP functions at the UC Irvine GMP facility.
Direct departmental staff while executing the functional mission and vision.
Establish strategic partnerships and implement risk-based quality programs for UC Irvine GMP operations.
Oversee the deviation and CAPA systems, change management processes, and quality management of vendors and service providers.
Ensure comprehensive compliance with FDA and all applicable GxP regulations and industry best practices.