- Pfizer (Collegeville, PA)
- **The Issue Lead will be responsible for...the efficiency of the process by which Pfizer conducts GCP investigations , and leveraging data to assess ... driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements,...the appropriate teams to perform interventions as needed.** **The Issue Lead will also triage submitted cases… more
- Takeda Pharmaceuticals (Boston, MA)
- …Program Quality, Deviation Management and Serious Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery ... Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management… more
- Endo International (Rochester, MI)
- …assesses the risk level associated with Non-Conformances and escalates the issue to management. Opportunities for continuous improvement of advanced technologies and ... teams + Works with contractors or other staff to ensure resolution of investigations , deviations and corrective actions, etc. + Responsible for investigations in… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Quality requirements and cur-rent industry trends and best practices. + Lead monitoring and management of quality events/deviations investigations to ... and develop achievable and sustainable actions to address the issue within the established timelines. + Host PV business...other regulatory authority inspections in all GxP areas (ie, GCP , GMP). + Evaluate adequacy and completeness of CAPAs… more