Quality Manager (GCP)

Planet Pharma; England; On-site; GBP 90,000 - 120,000; Full time

Job summary

A leading life science organization in the United Kingdom is seeking a GCP Quality Manager to ensure compliance with global regulatory requirements and ICH standards. The successful candidate will oversee quality oversight and manage GCP quality records, coordinate inspection readiness, and conduct audits. Candidates should possess a Bachelor's degree, 5+ years in Clinical Quality Assurance, and strong knowledge of regulatory frameworks like FDA and EMA. This permanent role offers competitive compensation based on skills and experience.

Qualifications

• At least 5 years’ experience in GCP-focused Clinical Quality Assurance.
• Strong working knowledge of ICH GCP and global regulatory frameworks.
• Experience supporting or participating in regulatory authority inspections.
• Experience with electronic quality systems and quality events management.
• Strong knowledge of ICH GCP and global regulatory frameworks.

Responsibilities

• Provide expert GCP quality oversight and guidance to clinical teams.
• Maintain and enhance GCP-related elements of the Quality Management System.
• Develop and execute risk-based GCP audit plans.
• Develop and execute risk-based GCP audit plans (sites, CROs, labs, internal processes).
• Coordinate inspection readiness activities across functions.
• Support health authority inspections (FDA, EMA, MHRA) including preparation and follow-up.
• Manage GCP quality records (deviations, CAPAs, change controls).
• Monitor CAPAs to closure and verify effectiveness.
• Draft and update SOPs, policies, and training materials to reflect evolving regulations.

Skills

GCP Quality Assurance

Regulatory frameworks knowledge (FDA, EMA, MHRA)

Quality documentation authoring

Risk-based GCP auditing

Microsoft Office proficiency

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

eDMS

LMS

eTMF

eTMF

Job description

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 [phone] – [e-mail]

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