Senior GCP Auditor
Remote (UK), occasional site travelFull-timeQuality Assurance
Applications close October 31, 2026
You will run the audit programme for a portfolio of sponsor clients — planning, conducting and reporting GCP audits of investigator sites, CROs and specialist vendors across the UK and EU.
This is a senior, client-facing role. You will be the person a Head of Quality calls when an MHRA or EMA inspection is announced, and the one who decides whether a CAPA genuinely closes a finding or merely documents it.
We are a small consultancy, so you will shape how we audit as much as you execute it.
Responsibilities
- Plan and lead risk-based GCP audits of investigator sites, CROs and vendors
- Write clear, defensible audit reports that distinguish critical findings from observations
- Review CAPA responses and challenge root-cause analysis that does not hold up
- Prepare sponsor teams for MHRA, EMA and FDA inspections, including mock inspections
- Mentor associate auditors and review their reports before issue
Requirements
- Six or more years in clinical quality assurance, with at least three leading audits independently
- Working command of ICH E6 (R3), EU CTR and applicable national regulations
- Experience of at least one regulatory inspection from the sponsor side
- Life sciences degree, or equivalent experience in a regulated clinical environment
- Willingness to travel roughly one week in four
Apply for this role
This position is no longer accepting applications.