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.
- Further responsibilities of QA GCP PV Manager will include:
- 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.
- Creating specific quality assurance SOPs and policies that adhere to regulatory requirements and expectations
- Liaising with early and late stage development teams, operational and technical services and clinical safety pharmacovigilance groups to ensure conformance with regulatory requirements globally, good clinical and PV practice and internal standards, and pro-actively integrating quality and process improvement to assure that company's QA is a full partner in development activities and that world class development standards are applied wherever the company does business
- Acting as an internal clinical and PV quality consultant to company's departments, overseas offices, and local and regional development teams
- Developing, performing, and managing an auditing program that encompasses all phases of clinical development and clinical safety pharmacovigilance and provides assurance that company regulatory, documentation and record-keeping requirements are met internally and externally at CROs, bio-analytical and clinical laboratories and investigator sites. This necessitates having open communication with global company locations and subcontractors
- Monitoring compliance with all regulatory requirements for the protection of human subjects.
- Monitoring and reviewing data collection to guard against serious GCP/GPVP non-compliance and fraudulent data capture, then applying systematic approaches to detect this. Qualifying and assessing CROs, bio-analytical and clinical laboratories, investigators sites and other providers via audits
- Interpreting relevant regulations and apply them to practical clinical research and development and pharmacovigilance programs. This is done in part by creating specific quality assurance SOPs and policies that adhere to regulatory guidance
- Liaising with regulatory agencies on clinical, laboratory and pharmacovigilance quality issues and manage and facilitate GCP and pharmacovigilance inspections at company facilities, EU based CROs, laboratories and investigator sites that support EU submissions and studies
- As QA GCP PV Manager you will have the following qualifications, skills and experience:
- Minimum of a BSc. degree in a scientific or related discipline and/or background in medical health profession (RN, medical technologist)
- Quality assurance experience with a world class quality organisation in the pharmaceutical / CRO industry.
- First-hand knowledge of drug development as a CRA, GCP compliance professional or other related function
- Knowledge of drug safety handling and processing
- Experience of direct dealings with regulatory agencies
- International experience is a plus; but at minimum, experiences working with diverse cultures and employees
- The ability to work with a wide variety of people and takes actions that are best for company versus any individual operating group
- The ability to coach both internal and external employees on ways to improve performance and leads training in QA subject matters
- Respect for and capitalises on cultural diversity and seeks out perspectives when developing strategies, both international and domestic
- The wherewithal to claim ownership of processes and results regardless of their outcome, as well as realising the contribution that others are making and giving credit to them when appropriate
- 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.
How to apply:
For more information or to apply for this QA GCP PV Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org.Click here to apply now