Quality Assurance (GCP) Manager

We're Hiring: Quality Assurance Manager

Location:Remote with |Full-time, Permanent

Sector:Clinical Research / Life Sciences

Clerkenwell 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 experiencedQuality Assurance Managerto join us in shaping the future of clinical research.

About the Role

This 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 Responsibilities

• Lead QA oversight across clinical and operational activities
• Develop and maintain the QMS, SOPs, and document control processes
• Conduct internal audits and vendor/system assessments
• Host and manage sponsor audits and regulatory inspections
• Ensure compliance with GCP, GDPR, and UK clinical trial regulations
• Support quality training, risk assessments, and CAPA management
• Collaborate cross-functionally on trial readiness and regulatory strategy

What We’re Looking For

• Extensive QA experience within a CRO or clinical research facility
• In-depth knowledge of GCP, CTIMPs, and UK clinical trial regulations
• Proven experience managing audits, CAPAs, and QMS processes
• Strong leadership, communication, and stakeholder engagement skills
• Formal 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.