Hendre Moolman is recruiting for a QA GCP PV Manager to join a company in the pharmaceutical industry on a permanent role in Buckinghamshire.
As QA GCP PV Manager you will be managing the functions of a fully functional GCP/GPVP Quality Assurance program that will assure all global company studies (Phase I through III) and clinical safety pharmacovigilance groups can withstand regulatory scrutiny not only from an EU perspective, but from regulators in all countries where the company studies and registers products.
Working with the global QA group in developing and implementing global QA GCP/GPVP objectives and audit schedules to include development related audits of CROs, investigator sites, laboratories and PV systems.
Monitoring compliance with all regulatory requirements for the protection of human subjects.
Quality assurance experience with a world class quality organisation in the pharmaceutical / CRO industry.
The ability to motivate and influence employees at all company levels, as well as at CROs and investigator sites.
Maintain current knowledge of GCP and pharmacovigilance regulatory issues and assure that related business needs are met.