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Senior Quality Assurance Manager

3 months ago

Parsippany, United States R&D Partners Full time

Title: Senior Manager - R&D Deviation and CAPA Management Hybrid - T/W/Th on-site

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

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