Director QA GCP (25% US travel) - (Bridgewater, NJ)

Title of Position: Director, Quality GCP Reports To: Vice President, Quality Supervises: US Quality Unit FUNCTION OF POSITION: Quality OVERALL SCOPE Directs and coordinates one- 2 GXP discipline(s). Responsible for independently performing domestic and international audits/inspections for client groups that ensure compliance to the FDA and other worldwide health authority regulations /guidelines, site SOPs, protocols, and industry standards, as applicable. This includes applying developed skills to assure management that the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with applicable regulations. Provides recommendations for corrective action and tracks corrective action commitments until closure. RESPONSIBILITIES: 30% Directs and coordinates activities related to 1 - two GXP discipline(s). Manages day-to-day activities at local site level.