Associate Clinical Operations Compliance Director

Role: Associate Clinical Operations Compliance Director supporting clinical research compliance in biopharma, with a focus on GCP adherence, risk management, vendor oversight, and inspection readiness. Responsibilities: develop and execute risk management strategies, support CAPA processes, collaborate with QA and cross-functional teams, and lead initiatives in training and inspection readiness, including mock inspections and site monitoring oversight. Qualifications: Bachelor's degree with 11+ years in biotech/pharma, or advanced degree with proportionate experience; deep understanding of industry regulations, quality systems, and GCP standards. High-Value: focus on clinical operations compliance, risk and issue management, GCP training, and inspection readiness within biotech/pharma R&D; experience in maintaining audit readiness and oversight of CRO performance; strong communication and analytical skills; may involve working across clinical, data management, and quality units. WorkSetup: not explicitly stated, but environment implies office-based with collaborative space.