Associate Director

New Today

Job Description

Associate Director, External Service Provider Quality Assurance

Global Pharmaceutical Organisation - Contract

London, UK 18-month contract - Hybrid


We are working with a leading global pharmaceutical organisation to appoint an Associate Director of External Service Provider Quality Assurance on an 18-month contract basis. This is a senior quality role within R&D, responsible for managing oversight of external service providers across a complex, international clinical development portfolio.


This role would suit someone who thrives in a matrix environment, is comfortable with complexity and has a track record of working across global teams.


Key responsibilities

  • Leading ESP qualification and quality oversight for global clinical trials and medical affairs studies
  • Negotiating and executing Quality Assurance Agreements with external service providers
  • Reviewing and approving quality risk assessments to identify risks, trends and potential issues proactively
  • Managing quality issues and escalating major and critical findings, including serious breach reporting to health authorities
  • Supporting Medical Affairs with management of research collaborations, non-interventional studies and real-world evidence
  • Collaborating cross-functionally with Global Medical Affairs, Vendor Governance, Procurement and Country Development Quality teams
  • Driving inspection readiness and supporting internal audits and health authority inspections


What we're looking for

  • 8+ years of Clinical Quality Assurance experience, including direct involvement in clinical trial conduct
  • 4+ years of clinical vendor management experience
  • Strong understanding of pharmaceutical regulations including GCP, GLP, GVP and GMP
  • Demonstrated experience working in matrix and global team environments with high learning agility
  • Experience working with Medical Affairs on non-interventional studies, research collaborations and real-world evidence
  • Strong stakeholder engagement, root cause analysis and critical thinking skills
  • Degree in Life Sciences, Pharmacy, Medicine or a related discipline


This role is based in London. Candidates must have the right to work in the UK. Relocation support is not available.


To find out more or to apply, please get in touch or apply directly through this advert. We look forward to hearing from you.

Apply
Location:
City Of London
Job Type:
FullTime
Category:
Technology

We found some similar jobs based on your search