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Date Added: Wed 26/05/2021

Sr. Manager/Associate Director ( Quality Systems )

Menlo Park, CA, US
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Job Type: Permanent, FullTime

Job Description
Job Description

Senior Manager/Assoc. Director, Quality Systems - Develop, implement, and maintain Clients internal GxP quality systems (paper and electronic).

  • Lead the Client effort for continuous improvement of the Quality Management System (QMS)
  • Lead the Client effort for the implementation of electronic Quality Management Systems (eQMS)
  • Manage the maintenance of SOPs, training programs, deviations, CAPAs, commercial/investigational product complaints, vendor qualification/auditing, and the documentation of these activities in the QMS
  • Organize and train personnel regarding regulatory agency inspection readiness of the QMS and assist during inspections
  • Develop and maintain systems for efficiently and securely storing GxP training materials, records, and documents supporting Client's commercial and development activities
  • Assist 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
  • 10+ years' experience in the development and maintenance of quality systems in commercial-stage pharmaceutical companies
Preferred 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

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