Executive Director, Clinical Quality Assurance
About the role
The Executive Director, GCP Quality Assurance provides strategic and functional leadership for GCP Quality across Aura Biosciences’ clinical development portfolio. This leader is accountable for establishing and advancing a risk-based, inspection-ready Clinical Quality framework that supports global clinical development and ensures compliance with applicable regulations, ICH guidelines, company procedures, and industry standards. The Executive Director serves as a senior Quality partner to Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and other cross-functional leaders, providing independent quality oversight, risk assessment, and strategic guidance throughout the clinical development lifecycle. This role leads GCP inspection readiness and sponsor inspection activities, including FDA BIMO inspections, and provides quality oversight of CROs and other critical clinical partners. The Executive Director is a member of appropriate cross-functional governance and clinical leadership forums and serves as a key Quality advisor to senior management on clinical quality risks, compliance, inspection readiness, and overall quality strategy.
Responsibilities
- Develop and lead the GCP Quality strategy and quality framework supporting Aura’s clinical development portfolio, with particular focus on pivotal and late-stage programs.
- Establish and continuously improve a risk-based Clinical Quality Management System encompassing auditing, quality events, CAPA, issue management, training, vendor oversight, and continuous improvement.
- Provide independent Quality leadership and strategic counsel to Clinical Operations, Clinical Development, Regulatory Affairs, and other GCP functions on complex compliance and quality matters.
- Establish GCP quality objectives, metrics, and leading indicators and provide strategic quality reporting, including contributions to Quality Management