SUMMARY
A senior quality leadership position within a specialist life sciences consultancy delivering regulatory, clinical, and compliance expertise across global markets. The role focuses on GCP compliance, clinical trial oversight, and quality management system development within a fast-paced consulting environment. Working across UK and European projects, the position combines hands-on audit delivery with strategic quality leadership, supporting both client-facing work and internal quality initiatives within a growing international team.
RESPONSIBILITIES
* Lead UK and EU compliance service delivery, supporting wider global quality operations
* Plan, manage, and conduct GCP audits including vendor qualification, system audits, trial audits, and inspection readiness activities
* Own audit outcomes, driving structured issue resolution and corrective/preventive actions (CAPAs)
* Perform quality management system gap analyses and develop compliant documentation including SOPs and policies
* Provide sponsor oversight for clinical trials, acting as representative with CROs, sites, and vendors
* Deliver GCP training programmes tailored to client requirements
* Support development and execution of global quality assurance initiatives
* Maintain and improve quality management systems and associated processes
* Act as escalation point for complex quality and compliance issues across projects
* Ensure quality documentation, audit reports, training materials, and CAPAs are delivered to a high standard
* Contribute to continuous improvement and service excellence across client engagements
* Maintain billable utilisation through delivery of technical consulting work
REQUIREMENTS
* Degree in life sciences or related discipline (BSc essential; MSc or PhD preferred)
* Minimum 5 years' experience in GCP auditing within clinical trials, vendors, systems, and inspection readiness environments
* Strong knowledge of ICH-GCP and regulatory compliance frameworks (GCP certification required)
* Proven experience writing SOPs and regulated quality documentation
* Experience in clinical trial oversight or sponsor-side quality assurance preferred
* Strong organisational and time management skills with ability to manage multiple priorities
* Demonstrated leadership or mentoring capability within technical teams
* Excellent communication, stakeholder management, and problem-solving skills
* Proficient in Microsoft Office and CRM systems
* Comfortable working autonomously and within international teams
* Willingness to travel within the UK, Europe, and occasionally internationally
TO APPLY
- Submit your CV highlighting relevant experience
- Applicants must be eligible to work in the UK without sponsorship requirements
gjohnstone@barringtonjames.com / +441293778666