Country Clinical Quality Manager

Overview

In this role you ensure clinical quality and patient safety for UK-sponsored trials, acting as the local expert on GCP and UK regulations. You collaborate with regional leadership to uphold data integrity and drive sustainable quality improvements. You lead readiness for audits and inspections, coordinate CAPAs, and guide quality control across sites. You’ll work with cross-functional teams to advance digital, AI-enabled quality oversight and continuous improvement. This is a mission-driven role with impact on patient outcomes and global quality standards.

Pay / Benefits

• hybrid work arrangements
• meaningful impact on patient outcomes
• global clinical quality networks exposure
• collaborative culture
• ethically-led leadership
• growth and empowerment opportunities

Responsibilities

• Local regulatory leadership on ICH-GCP and UK regulations; maintain and refine SOPs with Country Operations Management
• Lead country-level quality initiatives and contribute to regional/global enhancement projects
• Audit & inspection readiness; liaison with MHRA and QA bodies; drive CAPA plans
• Coordinate in-house quality control plans and Quality Control Visits (QCVs); trend identification and targeted corrective actions
• Lead escalation and investigations of quality, compliance, and privacy issues; conduct root-cause analyses
• Develop and deliver training needs with Learning & Development; build cross-functional study team capability
• Vendor and supplier qualification; oversee quality evaluations and requalifications to uphold QMS standards

Key requirements

• 6–8+ years in clinical research with direct monitoring or oversight experience
• In-depth knowledge of ICH-GCP and UK regulatory requirements
• Experience in Quality Management, audits/inspections and CAPA
• Experience with quality control visits/reviews and process improvement
• Interest or experience in digital/AI-enabled analytics for trend analysis and oversight
• Leadership experience in cross-functional teams and complex projects
• Strong communication and regulatory negotiation skills

• analytical mindset
• collaborative and cross-functional teamwork
• strong communication and diplomacy
• Quality Management System (QMS)
• CAPA management
• Quality Control Visits (QCVs) and audits

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