Associate Director, Clinical Quality (Remote Eligible)

Role: Lead GCP Quality Assurance for clinical trial portfolio, ensuring inspection readiness, risk-based quality oversight, and continuous improvement of quality systems. Responsibilities: develop and execute quality strategies for Study Execution Teams, oversee site and vendor quality, lead risk assessments and mitigation, manage regulatory inspections and responses, identify compliance gaps, and drive CAPA effectiveness. Qualifications: 12+ years in clinical quality or GCP compliance; Bachelor's degree or equivalent experience; deep knowledge of ICH-GCP, FDA CFR, and global regulations; proven track record supporting/regulating inspections and overseeing CRO/vendor quality. HighValue: extensive GCP quality leadership, inspection management, risk mitigation, Vendor oversight, GCP system enhancements, influence in matrix organizations, and experience supporting global regulatory bodies. WorkSetup: not specified; role likely involves cross-functional collaboration across clinical development team.