Mantell Associates
Mantell Associates is partnered with a specialised consulting, technology, and services firm fully focused on supporting R&D in the life sciences sector, who is looking for an experienced GCP Auditor to join the team on a contract basis.
This role will play a critical part in ensuring that clinical operations and trial conduct consistently meet high-quality standards and regulatory expectations.
GCP Auditor – Responsibilities:
- Lead and conduct Good Clinical Practice (GCP) audits across clinical trial processes, including investigator sites, sponsor systems, vendor engagements, and trial-related data management
- Develop and execute comprehensive audit plans and scopes, performing gap analyses and risk-based assessments as part of the audit framework
- Prepare polished and insightful audit reports, including observations, root cause analyses, and actionable remediation recommendations
- Collaborate with internal and client teams – Quality Assurance, Regulatory Affairs, Clinical Operations – to support audit follow-up and compliance closure
- Provide GCP training and coaching to trial stakeholders, reviewers, and support teams as necessary
- Support or participate in inspection readiness efforts and mock inspections, aligning client systems with regulatory standards
GCP Auditor – Requirements:
- Proven experience as a GCP auditor or QA professional – ideally within life sciences consulting or CRO environments
- In-depth knowledge of ICH-GCP guidelines, clinical trial lifecycle, data integrity principles, and regulatory audit processes
- Strong analytical thinking with the ability to deliver structured, high-quality written audit deliverables
- Excellent communication and stakeholder management skills, with a client-focused and collaborative mindset
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at 44 (0)20 3854 7700.