Quality Manager GCP

Role: Quality Manager (GCP) within Clinical QA supporting clinical activities, QMS development, and regulatory compliance. Responsibilities: conduct internal/external audits; oversee GCP, GVP activities; manage CAPAs, RCA, and quality issues; support inspection readiness and data integrity efforts; develop QA processes, SOPs, and provide training; collaborate cross-functionally to resolve quality issues and support regulatory audits. Requirements: 5-10 years in clinical QA, proven GCP/GxP expertise, strong knowledge of QMS, regulatory standards (ICH, GCP, GCLP), and clinical trial processes; bachelor’s degree or equivalent. Preferred: biotech/pharma industry experience, GMP knowledge, and familiarity with clinical development stages. High-Value: GCP/GxP compliance, audit management, risk assessment, regulatory inspection support, and experience in biotech/pharma. Work setup: remote with 30% travel; based in US or UK locations.