Single Sponsor Manager, Quality Assurance – 2-3 days in London City

Overview

In this role you will lead quality assurance activities to support audits and inspections, drive CAPA and process improvements, and ensure compliance with ICH-GCP and local regulations. You will collaborate with the Clinical Compliance Quality Management team to monitor trends and implement local SOPs, contributing to risk-based quality governance. The position offers a chance to shape QA practices across country operations and partner with cross-functional teams to deliver compliant, patient-centric solutions. You will work in a fast-paced, data-driven environment that leverages digital tools to enhance quality oversight.

Responsibilities

• Support audit/inspection activities and manage responses to findings
• Lead/root-cause analysis and CAPA management
• Maintain local SOPs and SME network; ensure alignment with global procedures
• Identify and escalate process improvement opportunities to CCQM Lead/Process Owner
• Coordinate and execute local QC activities (IHQCP, QCVs) and site visits as needed
• Escalate quality/compliance issues to operations and CCQM Lead; assist investigations and reporting of serious breaches

Key requirements

• Bachelor’s Degree
• Experience in clinical quality management with field monitoring or operations oversight
• Deep knowledge of Clinical Trial processes and quality tools
• Experience in cross-functional teamwork and project delivery
• Experience in quality management/compliance activities (CAPA, SOP management, training)
• Proficiency with digital tools and data analytics; familiarity with Power BI/Power Apps is a plus
• Knowledge of local regulations and ICH-GCP

• Cross-functional collaboration
• Analytical thinking
• Proactive problem-solving
• Power BI
• Power Apps
• Automation technologies

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