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About the Role
We are seeking an experienced, proactive Country Clinical Quality Manager (CCQM) to lead clinical quality management for Clinical Trials Operations across the United Kingdom. This role is an opportunity to shape patient outcomes on a national and global scale by setting gold standards in Good Clinical Practice (GCP), continuous improvement, and digitalized quality oversight.
Responsibilities
- Act as the local authority on ICH-GCP and evolving UK clinical trial regulations.
- Partner closely with Country Operations Management to maintain robust SOPs, evaluate regulatory impacts, and identify opportunities for continuous process refinement.
- Lead country-level quality initiatives and collaborate on regional and global enhancement projects.
- Serve as the primary local point of contact for internal quality assurance bodies and health regulatory agencies (e.g., MHRA).
- Lead inspection preparations, conduct root-cause analyses on findings, and drive meaningful, sustainable CAPA plans.
- Coordinate and execute comprehensive in-house quality control plans and Quality Control Visits (QCVs).
- Identify trends early, conduct ad-hoc site evaluations, and deliver targeted corrective strategies.
- Lead the escalation and investigation of significant quality, compliance, and privacy issues.
- Oversee investigations into clinical supply GCP inquiries.
- Partner with Learning & Development to assess local training needs and bridge operational knowledge gaps.
- Coach cross-functional study teams.
- Manage quality evaluations and requalifications of locally selected vendors and clinical suppliers.
Requirements
- Bachelor’s degree (or equivalent) in a relevant life sciences or healthcare discipline.
- 6–8+ years of dedicated clinical research experience, including direct field monitoring or monitoring oversight, with a track record of operational achievement.
- Experience within UK Country Operations is highly preferred.
- In-depth knowledge of ICH-GCP guidelines, local UK statutory requirements, and end-to-end clinical trial workflows.
- Direct experience in Clinical Quality Management, Quality Control visits/reviews, process improvement, and managing audits/regulatory inspections.
- Proven ability or strong interest in leveraging modern digital assistants, analytics, or AI-powered workflow tools.
- Demonstrated success leading cross-functional teams, managing complex projects, and influencing stakeholders.
- Exceptional written and verbal communication skills.
- Strong root-cause problem solving and objective, strategic analytical capability.
- High ethical integrity, discretion, and a collaborative, solutions-oriented approach to conflict resolution.
Skills
- Clinical Quality Management
- Clinical Research
- Clinical Study Design
- Clinical Trial Planning
- Clinical Trials Monitoring
- Conflict Management
- Good Clinical Practice (GCP)
- Operational Quality
- Performance Auditing
- Process Improvements
- Quality Control Management
- Regulatory Compliance
- Risk Management
Location
- United Kingdom
Work Type
- Full-Time
- Hybrid
Experience Level
- 6-8+ years
Education Level
- Bachelor's degree
About the Company
- We are a global healthcare leader driven by an inspiring purpose: to discover, develop, and deliver life-saving medicines, vaccines, and animal health products.
- We have a legacy of more than 125 years of ethical, forward-thinking science.
- We believe that world-class clinical research begins with uncompromised quality.