Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a (Sr.) Director, PV Compliance.
- Serve as the primary interface within Global PV for the coordination of activities related to global PV compliance and accountable for establishing and executing the PV compliance strategy worldwide
- Leads the development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations audits
- Ensures the compliance activities related to PV inspection/audit readiness for Global PV and partnering with QA to determine internal PV audit areas of focus
- Directs and manages team to execute compliance activities as defined in a PV quality plan including maintenance, collection, compilation and regular assessment of adequate PV compliance metrics related but not limited to expedited and periodic PV regulatory reporting to relevant regulatory authorities for case processing and aggregate safety reporting, and their timely and adequate distribution to LOCs and PV business partners
- Ensures the execution and the development of adequate PV compliance processes by the designated Drug Safety Officers (DSO) at the Local Operating countries (LOCs)
- Collaborates with QA to ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide
- Ensures the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits
- Collaborates with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities’ regulations worldwide
- Participates in and overseeing talent management strategies such as annual reviews, performance management, succession planning and employee development and retention
- Ensures execution of PV focused and related inspection/audit support globally audits
- Develops and implements PV systems in compliance with PV regulatory requirements worldwide in collaboration with the Global PV Standards
- Collaborates with the Global PV Training group in the development of training strategies to ensure that GPV processes meet PV compliance regulatory requirements worldwide
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.