Senior Quality Assurance Manager
4 weeks ago
Responsibilities:
Excellent employment opportunity for a Senior Manager in a Parsippany, NJ (preferred) or Foster City, CA area.
R&D Deviation and CAPA Management
R&D Quality and Medical Governance
Onsite - Tuesday/Wednesday/Thursday
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
Experience:
GxP experience is preferred
10+ years of experience in Biopharmaceutical experience
6+ years managing investigations (deviations, CAPA, etc.)
Experience writing investigations
Experience managing RCA
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