Quality Assurance (GCP) Manager

We\’re Hiring: Quality Assurance ManagerLocation: Remote with | Full-time, PermanentSector: Clinical Research / Life SciencesClerkenwell Health is a purpose-built Clinical Research Organisation (CRO) and Clinical Research Facility (CRF) focused on innovation and integrity in mental health and psychedelic research. We’re growing – and we’re looking for an experienced Quality Assurance Manager to join us in shaping the future of clinical research.About the RoleThis is a critical role for maintaining the highest quality standards across our clinical trials, ensuring compliance with GCP, GDPR, and international regulations. You’ll lead the QA function across both our CRO and CRF, manage audits and inspections, drive CAPA processes, and support the development of a robust Quality Management System (QMS).Key ResponsibilitiesLead QA oversight across clinical and operational activitiesDevelop and maintain the QMS, SOPs, and document control processesConduct internal audits and vendor/system assessmentsHost and manage sponsor audits and regulatory inspectionsEnsure compliance with GCP, GDPR, and UK clinical trial regulationsSupport quality training, risk assessments, and CAPA managementCollaborate cross-functionally on trial readiness and regulatory strategyWhat We’re Looking ForExtensive QA experience within a CRO or clinical research facility In-depth knowledge of GCP, CTIMPs, and UK clinical trial regulationsProven experience managing audits, CAPAs, and QMS processesStrong leadership, communication, and stakeholder engagement skillsFormal GCP training & auditing certification would be advantageous Why Join Us?At Clerkenwell Health, we value compassion, collaboration, innovation, and integrity. You’ll be part of a passionate team pioneering new approaches to mental health research in a dynamic and supportive environment.