Executive Director, Clinical Quality Assurance

Role: Senior GCP Quality Assurance leader overseeing clinical quality for Aura Biosciences’ development programs, including pivotal and late-stage trials. Responsibilities: develop and execute global GCP quality strategies, ensure inspection readiness, oversee CRO/vendor compliance, lead audits and risk assessments, and serve as primary interface for FDA BIMO and other inspections. Provide strategic counsel on compliance, risk management, and quality systems; influence cross-functional leadership; and promote a culture of quality and continuous improvement. Qualifications: Bachelor’s in life sciences; 15+ years in GCP QA within biotech/pharma; extensive experience in global clinical development, regulatory inspections, and risk-based quality oversight; deep knowledge of GCP, ICH, FDA requirements, and vendor management. Preferred: advanced degree, RQA-GCP certification, and knowledge of biologics and biologic development lifecycle. High-Value: focus on ocular cancer therapies (bel-sar), late-stage clinical programs, global regulatory inspections, and risk-based quality frameworks. Collaboration: senior leadership, clinical operations, regulatory, medical, and external vendors. Location: not specified, likely hybrid or onsite; travel requirements not detailed.