GCP Vendor Quality Associate Director
Posted Today by PE Global
£31 Per hour
Undetermined
Hybrid
London Area, United Kingdom
Summary: The Associate Director, External Service Provider Quality Assurance will oversee the qualification and quality assurance of External Service Providers (ESPs) for global clinical trials and medical affairs studies. This role involves negotiating Quality Assurance Agreements, reviewing Quality Risk Assessments, and ensuring compliance with regulatory requirements. The position requires collaboration with various business partners to manage risks and maintain inspection readiness. The contract is for 18 months and is based in London with a hybrid working arrangement.
Key Responsibilities:
- Review and approve External Service Providers (ESPs) qualification for global clinical trials and medical affairs studies.
- Negotiate and execute Quality Assurance Agreements (QAA) with ESPs.
- Review and approve external service provider Quality Risk Assessments (QRAs).
- Communicate and support mitigation of actions for potential risks.
- Review and approve quality issues related to ESPs and escalate major issues.
- Support assessment of serious breaches and reporting to health authorities.
- Collaborate with business partners to ensure involvement in risk evaluation and timely communication.
- Review quality metrics, monitoring, and reporting, including follow-up with line functions.
- Ensure inspection readiness of local ESP activities and support audits and health authority inspections.
- Ensure compliance with regulatory requirements and continuous improvement of quality processes.
Key Skills:
- Over 8 years of experience in Clinical Quality Assurance.
- More than 4 years of experience in Clinical Vendor Management.
- Experience working with Medical Affairs for Management of Research Collaboration and non-interventional studies.
- Strong understanding of regulations in the pharmaceutical industry.
- High learning agility and ability to work in a matrix environment.
- Experience dealing with complexity and working across global teams.
Salary (Rate): £30.50/hr
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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***