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Senior Manager, Quality Management Systems (QMS)

Employer
a Pharmaceutical company located in Redwood City, CA
Location
Redwood City, CA
Closing date
Jan 16, 2022

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Sector
Other
Organization Type
Corporate
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Senior Manager, Quality Management Systems (QMS)

RESPONSIBILITIES
  • Responsible for the development, implementation, and maintenance of the company's internal GxP quality systems (paper and electronic).
  • Leading the Quality Management System (QMS) continuous improvement efforts and electronic Quality Management Systems (eQMS) enhancement efforts
  • Acting as system super-user, globally assess impact of system changes to existing modules
  • Managing the maintenance of SOPs, training programs, deviations, CAPAs, commercial/investigational product complaints, vendor qualification/auditing, and the documentation of these activities in the QMS
  • Supporting QMS regulatory agency inspection readiness and assist during inspections
  • Developing and maintaining systems for efficiently and securely storing GxP training materials, records, and documents while supporting commercial and development activities
  • Assisting in Quality Systems management of QA Operations, Pharmacovigilance, and Clinical QA activities including the scheduling of GPVP and GxP internal and vendor audits and resolution of findings
  • Managing periodic reviews of eQMS; resolve and document discrepancies
  • Coordinating and supporting vendor support release activities
  • Coordinating and resolving issues with software/consulting vendors
  • Supporting and providing guidance to cross functional groups with system implementation projects


QUALIFICATIONS
  • Minimum 10+ years' experience in the development and maintenance of quality systems in commercial-stage pharmaceutical companies
  • Familiarity with ICH 10 & GAMP 5
  • Hands on experience with QMS system implementations
  • Skills, Qualifications, or Technical Proficiencies
  • Experience in developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations
  • Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical, and commercial products
  • Proficiency in the use of Veeva QualityDocs / QMS and ComplianceWire
  • Ability to manage external software and consultant vendors


EDUCATION
  • Bachelors' degree in a scientific field
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