A Global Medical Device company has requested support in sourcing a Global PV Quality Operations Director.
This is a Global function to be based preferably from their UK hub, as well as considering remote working.
Specialising in surgical technologies, orthopaedic and interventional solutions, The Director Pharmacovigilance Quality Operations is responsible for directing the MD Global PV operations team including:
– provide strategy, oversight and facilitation for the MD PV QMS
– PV Audits and inspections
– Tactical implementation of PV directives
– Overall compliance with GVP for the clients products
– A senior professional with energy to build and lead a team of direct reports, responsible for oversight of MD PV operations.
– Accountability to ensure a sustainable and strong level of inspection readiness across the MD PV operational landscape, the Director will be expected to provide adequate training to promote organic growth within the PV Quality Operations team.
– BS Hons or Masters Degree (Preferred)
– Strong combined experience in Pharmacovigilance, Regulatory, Compliance, Quality Management and/ or operations in Medical Devices and/or Pharmaceutical environment
– Knowledge of global pharmacovigilance regulatory requirements and guidelines (EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP), 21 CFR 314, for drug/medicinal/biologic
– Line management/ development for direct reports
– 25% regional and international travel
If you are interested in hearing more about the opportunity, please contact Elliot Payne on 0203 393 5906 or email@example.com