Associate Director, Clinical Study Quality Lead (Hybrid)

Role: Associate Director/Clinical Study Quality Lead (SQL) overseeing GCP compliance and quality assurance for clinical trials across assigned disease areas, ensuring adherence to regulations and internal standards. Responsibilities: develop and execute audit/quality plans, identify and mitigate compliance risks, oversee inspection readiness, conduct audits, review investigations and CAPAs, monitor key quality metrics, and support continuous process improvement. May include line management duties. Requirements: Bachelor's in a scientific or health-related field, 8+ years' experience in clinical quality assurance, in-depth knowledge of ICH-GCP, global regulations (FDA, EMA, MHRA), and experience with drugs and biologics clinical development. Skills: risk-based quality oversight, audit planning, investigation, and metrics analysis, proficient in MS Office and quality management systems. Preferred: experience with medical devices, Cell and Gene Therapy, professional GCP certifications (e.g., CCRP). High-Value: GCP compliance, audit management, inspection preparedness, clinical trial oversight in biologics/drugs, cross-functional collaboration, up to 10% travel. Work setup: hybrid or on-site in a flexible work model.