Sr Manager

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