Executive Director, Clinical Quality Assurance

Executive Director, GCP Quality Assurance

Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potentially transformative, first-in-class therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of Bel-sar in early choroidal melanoma, the largest patient segment of uveal melanoma, is fully enrolled, and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing.

Aura's mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life.

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.

Key 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 Review and senior leadership governance.
• Identify emerging compliance and quality risks, assess their potential impact on clinical programs and regulatory submissions, and ensure appropriate escalation and remediation.
• Promote a culture of quality, accountability, and proactive risk management across clinical development.

• Provide strategic Quality oversight of global CROs, investigators, vendors, and other external partners supporting clinical development.
• Establish risk-based qualification, oversight, monitoring, and ongoing performance assessment processes for GCP and GLP vendors, including Approved Vendor List governance.
• Partner with Clinical Operations to ensure appropriate oversight of critical vendors and effective management of quality and compliance risks.
• Provide Quality input into clinical development strategies, protocols, informed consent forms, Clinical Study Reports, and other key clinical documentation, as appropriate.
• Ensure significant quality events, audit findings, and compliance issues are appropriately investigated, risk assessed, remediated, and trended.

• Lead the development and execution of a risk-based GCP audit strategy encompassing clinical systems, processes, investigator sites, CROs, vendors, and computerized systems, as applicable.
• Provide strategic oversight of audit observations, inspection findings, CAPAs, and remediation plans, ensuring actions are scientifically sound, risk-based, timely, and sustainable.
• Identify systemic compliance trends and quality risks and drive cross-functional remediation and continuous improvement.
• Provide senior-level oversight of root cause analysis, quality event management, CAPA effectiveness, and quality risk management.
• Ensure GCP procedures, training, and quality processes evolve in…