Associate Director – External Service Provider Quality Assurance (18‑month contract)

About the role

This 18‑month contract position supports a leading multinational pharmaceutical client in London. The Associate Director will lead the quality assurance function for external service providers (ESPs) involved in global clinical trials and medical‑affairs studies.

Key responsibilities

• Review and approve ESP qualification for clinical trials, Real‑World Evidence, PASS, NIS and other medical‑affairs studies.
• Negotiate and execute Quality Assurance Agreements and quality terms with ESPs.
• Assess and approve Quality Risk Assessments to identify metrics, risks, trends and potential performance issues, and drive mitigation actions.
• Manage escalation of major and critical quality issues, support breach assessments and reporting to health authorities.
• Collaborate with Global Medical Affairs, Vendor Partnership, Study Startup, Country Development Quality and Procurement to ensure risk evaluation and timely communication.
• Monitor quality metrics, produce reports, and follow up with line functions.
• Ensure inspection readiness, support internal/external audits and health‑authority inspections for ESP activities.
• Maintain compliance with GCP, GLP, GVP, GMP and drive continuous improvement of quality processes.

Required profile

• More than 8 years of experience in Clinical Quality Assurance, including hands‑on trial conduct.
• Over 4 years of experience in Clinical Vendor Management.
• Experience working with Medical Affairs on research collaborations, non‑interventional studies and Real‑World Evidence.
• Strong understanding of pharmaceutical regulations.
• High learning agility, ability to work in a matrix environment and across global teams.

Required skills

• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Pharmacovigilance Practice (GVP)
• Good Manufacturing Practice (GMP)
• Quality Risk Assessment (QRA)