Senior Quality Assurance Manager

3 weeks ago


ParsippanyTroy Hills, 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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