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
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services
Quality Manager (GCP) employer: Planet Pharma
At Planet Pharma, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of AI and healthcare. Our commitment to employee growth is reflected in our comprehensive training programmes and mentorship opportunities, ensuring that you can advance your career while making a meaningful impact on patient outcomes. Located in a vibrant area, we provide a competitive benefits package that supports work-life balance and promotes well-being.
