<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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