Associate Director - Clinical Operations Quality Assurance

This role is responsible for leading and managing the GCP external audit program, including designing procedures for sponsor QA responsibilities and site quality audits. The Associate Director will provide oversight and monitoring of investigational sites and third-party organizations, establishing risk-based quality oversight of GCP external organizations. They will support GCP operations in decision-making related to patient safety, efficacy data, and product quality, including deviation and CAPA management. Responsibilities also include evaluating the quality systems, operational controls, facilities, and personnel qualifications of potential third-party organizations. The role involves aligning and implementing global QMS standards, conducting internal audits and self-assessments, and educating personnel on GCP inspection trends. Continuous improvement of the GCP QMS, ensuring adequate procedures for document management, performance management, change control, deviations, complaints, computer systems, data integrity, risk analysis, training, and audit management are also key duties. Collaboration with team members to ensure visibility of performance and risks, and escalating performance issues to management are also required.