Quality Manager

4 weeks ago


Foster City, United States eTeam Full time

Job: Senior Manager R&D Deviation and CAPA Management R&D Quality and Medical Governance Onsite - T/W/Th Location - Parsippany, NJ (preferred) or Foster City, CA

Primary Responsibilities • 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

Candidate Requirements • GxP experience is preferred • 10+ years experience in Biopharma experience • 6+ years managing investigations (deviations, CAPA, etc) • Experience writing investigations • Experience managing RCA • Self motivated

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