Senior Clinical Quality Operations Manager

Role: Senior Clinical Quality Operations Manager responsible for executing operational quality management and inspection readiness across Eikon’s clinical development programs. Responsibilities include implementing quality-by-design principles, managing risk-based quality plans, overseeing vendor and CRO performance, and ensuring compliance with global GCP standards, including FDA, EMA, and other authorities. The role involves collaboration with Clinical R&D teams, Clinical Quality Assurance, and cross-functional stakeholders to maintain inspection readiness, support CAPA processes, and drive continuous process improvements. Requirements: minimum of 8+ years of experience in clinical operations or quality, in-depth knowledge of GCP, ICH guidelines, and risk management tools; Bachelor's degree (postgraduate preferred), certifications like Lean Six Sigma or PMP are a plus. HighValue: focus on clinical trial quality and inspection readiness in a cutting-edge biopharma setting with emphasis on GCP compliance, risk-based quality management, and cross-disciplinary collaboration. WorkSetup: onsite minimum 3 days/week; international regulatory knowledge essential.