Quality Manager (GCP)

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 –

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