Associate Clinical Operations Compliance Director (Biotechnology Oncology)

Role: Associate Clinical Operations Compliance Director supporting oncology clinical research, focusing on GCP compliance, risk management, vendor oversight, and inspection readiness. Responsibilities: contribute to risk/issue management strategies, support CAPA processes, liaise with Quality Assurance and cross-functional teams, and drive inspection preparedness including mock audits and BIMO responses. Oversight areas include training and capability, audit readiness, and monitoring oversight. Requirements: Bachelor's degree with 11+ years (or advanced degree with fewer years) in biotech/pharma; extensive industry experience; strong knowledge of biopharma regulations, quality systems, and GCP standards; excellent analytical, communication, and organizational skills. Preferred: experience in oncology clinical trials, risk-based monitoring, and inspection management. High-Value: oncology focus, GCP compliance, risk management, inspection readiness, and cross-functional collaboration. Work setup: Office-based environment with a collaborative, modern workspace.