- 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
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Lilly (Boston, MA)
- …close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP , ICH) using a risk-based approach. + Develop and implement operational ... the planning of quality assurance activities and coordinate remediation of audit findings. + Lead vendor selection, contract/budget negotiation, and management… more
- Parexel (Providence, RI)
- **Job Purpose:** The Senior Clinical Research Associate I (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 Reg unit, the Regulatory Operations Manager (ROM) will ... to monitor and ensure regulatory document collection and maintain compliance and audit -ready state. Assist in audit preparations and represent the department… more