Quality Assurance Manager
About the role
The Senior Manager of Quality Assurance will lead the GxP functions at the newly constructed cGMP facility at UC Irvine. This facility supports clinical trials of cell therapeutics and Chimeric Antigen Receptor (CAR) T-cells.
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.
Requirements
- Demonstrated management skills, with progressive expertise in quality and process improvement methodologies, statistical analysis, and data base management.
- Prioritized organizing, managing multiple priorities, meeting deadlines, and assigning 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.
- In-depth knowledge of QA principles, concepts, industry practices, and standards.
- Hands-on experience in Quality Risk Management principles and tools (e.g., FMEA, RCA).
- Adherence to excellent customer service principles.
- Technical vocabulary to meet facility needs.
- Working knowledge of cGMPs, GLPs, and associated regulatory requirements for the manufacture, testing, and release of clinical products.
- Working knowledge of Six Sigma, DMAIC methodology, and/or quality improvement statistical tools.
- Must possess technical vocabulary to meet facility needs.
- Must be able to write clear technical reports in the scientific format.
- 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.
- 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
Additional 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
- 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.
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 along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.