Senior Clinical Quality Operations Manager

Role: Senior Clinical Quality Operations Manager (Sr. CQOM) responsible for executing operational quality management and inspection readiness activities in Eikon's clinical development programs. Responsibilities include implementing quality-by-design principles, developing risk-based quality plans, overseeing vendor and CRO performance, and ensuring compliance with global GCP standards, including FDA, EMA, and other authorities. The Sr. CQOM partners cross-functionally to monitor quality metrics, lead CAPA processes, and prepare for inspections, supporting continuous process improvements. Qualifications: minimum 8+ years of experience in GCP-compliant clinical operations with a Bachelor’s degree; advanced certifications like Lean Six Sigma or PMP preferred. Deep knowledge of GCP, ICH E6(R3), risk management tools, and quality planning in clinical trials is required. Experience with CAPA management, risk-based approaches, and quality management systems such as Veeva is advantageous. High-value: focus on clinical quality assurance within early-phase (likely Ph1-3) clinical trials, emphasizing inspection readiness, risk mitigation, and quality standards adherence. Collaboration involves clinical development, CQA, regulatory, and study teams. Work setup: onsite at least 3 days/week, with international regulatory oversight responsibilities.