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Quality Manager

4 months 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