- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **ABOUT THE ROLE** The Associate Director , GCP Audit & Compliance provides strategic quality ... adherence to GCP , GCLP, and GVP standards. This role combines audit leadership, supplier oversight, and strategic risk management to enhance end-to-end clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit , etc.) to Global Quality and R&D Quality. Present to CPMQ at… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The Sr. CRA is accountable...applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective… more
- Dana-Farber Cancer Institute (Boston, MA)
- …well as assist with FDA submissions and IND management. Reporting to the CTIP Associate Director for the Pediatric unit, the Regulatory Operations Manager (ROM) ... to monitor and ensure regulatory document collection and maintain compliance and audit -ready state. Assist in audit preparations and represent the department… more