Quality Manager (GCP)
il y a 6 jours
Oxford
Job Title: 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 organisation’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 organisation-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 – 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