GVP Auditor

We're recruiting for a globally respected CRO seeking a UK-based Remote GCP Auditor. This role ensures patient safety and regulatory compliance across international clinical trials through expert auditing of clinical sites, processes, and documentation.

Core Responsibilities

1. Conduct Risk-Based Audits:

   • Lead remote audits of Clinical Investigator Sites, Vendors (Labs, CROs), TMF/eTMF, and Clinical Systems across UK/EU

   • Apply risk-based methodologies to prioritize audit targets

2. Ensure Regulatory Compliance:

   • Verify adherence to ICH-GCP, UK Clinical Trials Regulations, MHRA requirements, and GDPR

   • Monitor CAPA effectiveness post-audit/inspection

3. Audit Management:

   • Issue detailed audit reports (critical/major/minor findings) via eQMS (e.g., Veeva)

   • Maintain comprehensive audit documentation

4. Support Inspections:

   • Host/support MHRA, EMA, and FDA inspections as GCP subject matter expert

5. Training & Collaboration:

   • Deliver GCP training to clinical teams

   • Advise on quality issues with Clinical Operations and Data Management

Essential Requirements

• Residency: Must be UK-based with right to work

• Education: Bachelor's/Master's in Life Sciences or related field

• Experience:

  • 3+ years GCP auditing in CROs/Pharma

  • Proven experience auditing Clinical Sites and TMF

• Regulatory Knowledge: ICH-GCP, UK Clinical Trials Regulations, MHRA expectations

• Technical Skills: eQMS (Veeva preferred), MS Office, remote auditing tools

• Language: Fluent English

Preferred Profile

• GCP Auditor certification (RQAP-GCP)

• Experience with risk-based monitoring (RBM)

• Knowledge of ATMPs (Advanced Therapy Medicinal Products)

What We Offer

• Fully remote working within UK

• Competitive salary + performance bonus

• Private healthcare + enhanced pension

• 25 days holiday + flexible hours

• Global development programs