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Senior Manager, Quality Systems

Company: EPM Scientific
Location: Redwood City
Posted on: June 20, 2022

Job Description:

Job Title : Senior Manager, Quality SystemsSummary : Looking for an opportunity to work with cutting edge oncology technology? Are you someone who is interested in taking on a challenge and being a part of a company who's innovations could be one of the biggest steps in curing cancers? My client is one of the world's most innovative biotechnology companies that is looking to allow for more life in their patients by engineering cell therapies that are safer, more effective and more accessible to all who need it. Using their novel D-Domain technology allow for improved target specificity when used in CARs while enhancing binding affinity. If you are looking to become part of a team that is breaking down walls in cancer research, this may be the opportunity for you!The Senior Manager, Quality Systems will be responsible for :

  • Executing day-to-day management of an electronic document management system (complaints, document management, training, change control)
  • Implement and enhance various components of QMS to ensure adherence to standards and compliance with regulatory requirements.
  • Maintain SOPs, training programs, deviations, CAPAs, complaints, vendor qualifications/auditing.
  • Provide day to day support to QMS requests and/or issues.
  • Create and provide QMS Key Performance and Key Quality Metrics to upper management.The Senior Manager, Quality Systems should have the following requirements :
    • Bachelor's Degree in a Life Sciences or technical discipline.
    • At least 7-9 years GxP and Quality in Biotech or Pharma environment.
    • Experience implementing and managing eQMS.
    • Extensive knowledge of applicable US and Global compliance regulations and industry practices.
    • Experience in Inspection Readiness and participating in high performing teams.If this sounds like something you would be interested in, please apply!

Keywords: EPM Scientific, Redwood City , Senior Manager, Quality Systems, Executive , Redwood City, California

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