Rate: Competitive in line with skills / experience
Type: Permanent
My client a specialist life science organization currently has urgent need for a GCP Quality Manager to join on a permanent basis. This role is accountable for maintaining compliance with global regulatory requirements, ICH Good Clinical Practice standards, and internal quality procedures.
Key Responsibilities
- Provide expert GCP quality oversight and guidance to cross-functional clinical teams
- Maintain and enhance GCP-related elements of the organization’s Quality Management System
- Support the assessment, qualification, and ongoing monitoring of clinical service providers and vendors
- Develop and execute risk-based GCP audit plans, including audits of sites, CROs, laboratories, and internal processes
- Coordinate organization-wide inspection readiness activities, ensuring consistent preparedness across functions
- Support health authority inspections (FDA, EMA, MHRA), including inspection preparation, participation, and follow-up
- Manage GCP quality records such as deviations, CAPAs, and change controls, ensuring timely and compliant closure
- Monitor corrective and preventive actions to completion and confirm effectiveness
- Draft, review, and update SOPs, policies, and training materials to reflect evolving regulations and best practices
Required Experience & Skills
- Bachelor’s degree in a scientific discipline or equivalent relevant industry experience
- At least 5 years’ experience in GCP-focused Clinical Quality Assurance
- Practical experience managing quality events and working within electronic quality systems
- Strong working knowledge of ICH GCP and global regulatory frameworks (FDA, EMA, MHRA)
- Qualified GCP auditor with demonstrated experience across investigator sites, vendors, and systems
- Thorough understanding of clinical trial conduct, documentation, and lifecycle expectations
- Experience supporting or participating in regulatory authority inspections
- Proven capability in authoring and maintaining controlled quality documentation
- Proficiency with Microsoft Office and clinical systems such as eQMS, eDMS, LMS, and eTMF
Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631 – mowusu-ansah@planet-pharma.co.uk
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