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QA Operations Manager

  • Location: South San Francisco
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 9 days ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 22 December 2022
  • Job Ref: JN -112022-475546

QA Operations Manager

South SF, CA




Summary

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).




Responsibilities

  • Manage daily QA operations at the 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 complaint 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

Qualifications

  • BS 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 a huge plus



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