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Quality Assurance Manager

4 weeks ago

San Mateo, United States Integrated Resources Full time

Title: Sr Manager- Quality Assurance

Location: HYBRID- Parsippany, NJ (preferred) or Foster City, CA

Onsite visit on T/W/Th

Duration: 6 Months

Description:

  • R&D Deviation and CAPA Management
  • R&D Quality and Medical Governance
  • Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts.
  • Build, deploy and reinforce learning tools and materials to support quality event management capability development.
  • Oversee the standard and timeliness of deviation and CAPA completion.
  • Work with the business process owners to identify issues and improvement requirements and lead those improvement initiatives.
  • In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes.
  • Administer notification to management and escalation process.
  • Participate in risk assessments and act as risk facilitator.

Requirements:

  • GxP experience is preferred.
  • 10+ years' experience in Biopharma experience.
  • 6+ years managing investigations (deviations, CAPA, etc).
  • Experience writing investigations.
  • Experience managing RCA

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