Executive Director, Product Quality

Role: Executive Director, Product Quality at Aura Biosciences, leading the company's product quality strategy across the entire lifecycle from late-stage clinical development to commercialization and lifecycle management. Responsibilities: develop and implement quality strategies, oversee CMC, manufacturing, analytical, and testing activities, ensure inspection and regulatory readiness, and lead external partner quality management. Collaborate closely with Technical Operations, Regulatory Affairs, Supply Chain, and Clinical Development to embed quality into business decisions, manage risks, and support BLA submissions. Build and develop a high-performing quality organization capable of supporting Aura's transition to a commercial-stage company. Requirements: MS or PhD in Pharmaceutical Sciences, Analytical Chemistry, or related field; 15+ years of pharmaceutical/biotech quality experience, including 8+ years in senior leadership roles; extensive biologics and large-molecule product knowledge; experience supporting BLA submissions and regulatory inspections; proven ability to lead cross-functional teams, influence senior stakeholders, and operate in fast-paced biotech environments. HighValue: biologics, large molecules, biologic-small molecule products, late-stage development, BLA readiness, manufacturing, external testing, regulatory inspections, product lifecycle, and global compliance. WorkSetup: Not specified, but travel domestically and internationally is required.