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Quality Systems Manager

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

Posted 10 days ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 21 December 2022
  • Job Ref: JN -112022-475547

<span id="mce_marker" data-mce-type="bookmark">​</span><span id="__caret">_</span>Quality Systems Manager

South SF, CA

Summary

The ideal candidate is an experienced Quality Systems 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, etc.)

Responsibilities

  • Responsible for the oversight and governance of Quality Systems and processes related to:
    • Change Management
    • Corrective Action and Preventive Action (CAPA)
    • Quality System Deviations
    • Nonconformances
    • Out of Service Notifications
    • Investigations
    • Quality System records
  • Manage and improve daily operations of current eQMS workflows in support of the above continuous improvement systems
  • Provide coaching and mentoring to junior staff
  • Continually evaluate systems and implement procedures to improve efficiency and compliance to applicable regulatory requirements and standards
  • Provide training and guidance on Quality topics to foster a quality culture and quality mindset (i.e. technical writing, investigation write-ups)
  • Provide timely support and review of investigations to ensure timely closure
  • Provide timely follow up with functional departments for timely completion of investigations and implementation of corrective and preventive actions
  • Monitor Quality Systems for trends and notify management of events requiring immediate action
  • Define quality metrics, analysis trends, and reports specific KPIs for quality management review as required
  • 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 at 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
  • Experience developing and implementing QMS for FDA-regulated pharmaceutical products
  • 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 or managing eQMS, such as MasterControl or Veeva
  • Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolution skills
  • Strong teamwork, leadership, organization, and communication skills
  • Experience in cell & gene therapy is a huge plus



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