Director/Associate Director, Clinical Quality Assurance

2 weeks ago


City of London, United Kingdom Proclinical Staffing Full time

Job DescriptionAre you passionate about quality and precision? Join our client's Clinical Quality Assurance team and help ensure top-tier standards every day.Proclinical is seeking an Associate Director/Director of Clinical Quality Assurance to lead the development, implementation, and continuous improvement of clinical QA systems. In this role, you will ensure compliance with ICH-GCP, EU, and local regulatory requirements for clinical research activities. You will oversee internal and external clinical quality activities, provide strategic input into R&D processes, and prepare for regulatory inspections. This position involves building and managing a fit-for-purpose CQA function while serving as a subject matter expert and advocate for clinical quality. Responsibilities:Develop, implement, and maintain a risk-based clinical quality management system aligned with regulatory requirements (e.g., ICH-GCP, EU Clinical Trials Regulation).Support clinical study teams in interpreting and applying GCP standards and internal SOPs.Lead preparation, hosting, and follow-up for regulatory agency GCP inspections and clinical quality audits.Conduct and manage internal and external CQA audits, including sites, vendors, CROs, and study documents/data.Oversee CAPA (Corrective and Preventive Action) processes, support root cause analysis, and ensure timely r...



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