Manager/Sr Manager, Quality Assurance (Person In Plant) - (Redwood City, CA)

Overview: Representing the quality organization in oversight and monitoring of the GMP production in contract manufacturing sites to ensure product specifications are met. Principle Responsibilities and Duties: * Batch Records Review and Release. * Drives and troubleshoots quality investigations at contract manufacturers to ensure that all critical quality issues are fully investigated with appropriate action. * Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections. * Quality review of documents from contract manufacturers for compliance with Coherus BioSciences policies and procedures. * Execute and oversee Coherus BioSciences vendor management key performance indicators at contract manufacturers. * Identify and maintain risk management activities for the CMOs present status at relevant Quality Meetings.