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Senior Manager
4 weeks ago
Position: Senior Manager Location: Parsippany, NJ (preferred) or Foster City, CA Duration: 6 Months Job Type: Contract Work Type: Hybrid Job Description 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
- 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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