Manager, QA Operations
South San Francisco, CA
The ideal candidate is an experienced Quality Assurance Operations Manager with a track record of success in GMP environments who understands biologics processes (i.e., cell & gene therapy, aseptic environments, reagent control, contamination control). The candidate will be responsible for the following in support of maintaining the highest quality products.
- Manage daily QA operations at SSF site in support of cell & gene therapy manufacturing activities
- Provide coaching and mentoring to junior staff
- Review and approve all GMP documentation including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols and summary reports, etc.
- Provide document review and feedback for CAL/PM program and Environmental Monitoring for the site
- Manage and trend lot/product disposition activities
- Define quality metrics, analysis trends, and report client (product) specific quality metrics for quality management review as required
- Provide training and guidance on Quality topics to foster a quality culture and quality mindset (i.e., Good Documentation Practices)
- Manage the Material Review Board program for in-house and purchased materials
- Provide compliant investigations, review and approve investigations as needed
- Provide overall direction to Quality and non-Quality personnel performing raw material review and release activities, analytical data reviews and general analytical support
- Maintain tracking databases associated with data review and lot disposition activities
- Support finished product shipments to clinical site in conjunction with logistics/clinical and supply chain functions
- Support Tech Transfer activities for new projects
- Participate in quality audits in support of GMP operations and regulatory requirements
- Partner with Program Management, Manufacturing, Quality Control, Supply Chain and attend meetings in support of relevant manufacturing programs and activities
- Present data during department and cross-functional meetings as needed
- Perform other activities as required based on company needs
- A Bachelor's degree or higher in a relevant scientific discipline - Bioinformatics, Biology, Biochemistry, Chemistry or other relevant area.
- A minimum of 8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities
- Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs such as, 21 CFR Part 210 and 211
- Must have extensive cGMP quality system knowledge and experience.
- Experience using and or managing eQMS, such as MasterControl or Veeva
- Strong interpersonal skills, ability to work in a team environment, attention to detail and excellent problem resolution skills
- Strong teamwork, leadership, organization, and communication skills.
- Experience in cell & gene therapy is a plus