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 managementDevelop and execute comprehensive audit plans and scopes, performing gap analyses and risk-based assessments as part of the audit frameworkPrepare polished and insightful audit reports, including observations, root cause analyses, and actionable remediation recommendationsCollaborate with internal and client teams - Quality Assurance, Regulatory Affairs, Clinical Operations - to support audit follow-up and compliance closureProvide GCP training and coaching to trial stakeholders, reviewers, and support teams as necessarySupport 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 environmentsIn-depth knowledge of ICH-GCP guidelines, clinical trial lifecycle, data integrity principles, and regulatory audit processesStrong analytical thinking with the ability to deliver structured, high-quality written audit deliverablesExcellent 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.