PE Global is currently recruiting for an Associate Director, External Service Provider Quality Assurance for an 18 month contract role with a leading multinational Pharma client based in London (hybrid).
Job Responsibilities
- Responsible for review and approval of External Service Providers (ESPs) qualification for global clinical trials and medical affairs studies (RCs, PASS, NIS etc).
- Responsible for negotiation and execution Quality Assurance Agreements (QAA) / quality terms with of ESPs.
- Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the of local ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks.
- Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues. Support assessment of serious breach and reporting to health authorities.
- Collaboration with business partners such as, Global Medical Affairs, Vendor Partnership and Governance, Study Startup Organisation, Country Development Quality and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.
- Ensure inspection readiness of local ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining local ESP management.
- Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.
Requirements:
- >8 years experiences with Clinical Quality Assurance (e.g. involvement in clinical trial conduct)
- > 4 years experiences with Clinical Vendor Management
- Experiences working with Medical Affairs for Management of Research Collaboration, non interventional studies, Real world Evidence etc.
- Strong understanding of regulations in pharmaceutical industry
- High learning agility, working in matrix environment, can deal with complexity and worked across global teams
Interested candidates should submit an updated CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***