Executive Director, Product Quality

About Aura
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.
For more information, visit
aurabiosciences.com. Follow us on X, @AuraBiosciences, and visit us on LinkedIn.
Position Summary
Aura Biosciences is seeking an experienced, strategic, and highly collaborative Executive Director, Product Quality to serve as the Company's senior operational Product Quality leader and a key member of the Quality leadership team.
Reporting directly to the SVP, Quality, the Executive Director will serve as the SVP's principal operational partner in the development and execution of Aura's Product Quality strategy across the product lifecycle, with particular emphasis on late-stage development, BLA readiness, commercial manufacturing, launch readiness, and lifecycle management.
The Executive Director will provide senior Quality leadership across Product Quality, CMC, manufacturing, analytical and QC activities, external manufacturing and testing partners, supplier quality, technology transfer, validation, stability, specifications, product quality risk management, and commercial readiness.
This leader will partner closely with Technical Operations, CMC, Regulatory Affairs, Supply Chain, Clinical Development, and other functions to integrate Quality into business and product decisions; identify emerging risks; drive timely resolution of significant issues; and provide clear, risk-based recommendations to the SVP, Quality and executive leadership.
The Executive Director will also work closely with the leaders of Quality Control, Quality Systems, GCP Quality, Device Quality, and other Quality functions to ensure an integrated and consistent Quality strategy across Aura.
This is a highly visible leadership position with significant responsibility for BLA submission and inspection readiness, commercial product readiness, external partner performance, and building a scalable Product Quality organization capable of supporting Aura's transition to a commercial-stage company.
Key Responsibilities
Product Quality Strategy & Leadership
Serve as the SVP, Quality's principal operational partner for Product Quality and CMC Quality matters.
Develop and execute Product Quality strategy across the lifecycle from late-stage clinical development through BLA submission, approval, commercial launch, and lifecycle management.
Establish Product Quality priorities, governance, metrics, and organizational capabilities aligned with business and portfolio objectives.
Provide strategic Quality input to company, portfolio, CMC, manufacturing, supply, and product development strategies.
Identify, assess, and escalate significant Quality risks and provide clear, risk-based recommendations to senior leadership.
Ensure Quality resources are appropriately prioritized based on patient risk, regulatory expectations, business priorities, and product lifecycle stage.
Drive a culture of proactive Quality ownership, scientific rigor, accountability, and continuous improvement.
CMC, Manufacturing & Product Quality
Provide senior Quality oversight across CMC, drug substance and drug product manufacturing, and product quality activities supporting clinical and commercial products.
Partner with Technical Operations and CMC to ensure robust, scientifically sound, compliant, and commercially appropriate manufacturing and control strategies.
Provide Quality leadership for manufacturing site selection, qualification, onboarding, technology transfer, site changes, process validation, continued process verification, analytical method transfer and validation, and commercial readiness.
Ensure risks associated with manufacturing processes, materials, suppliers, equipment, facilities, analytical methods, and manufacturing sites are appropriately assessed and controlled.
Participate in strategic decisions regarding manufacturing network design, CMO selection, capacity, supply continuity, and lifecycle strategy.
Provide Quality oversight of specifications, control strategies, stability, deviations, investigations, CAPAs, changes, and product disposition.
Establish appropriate governance and escalation for significant CMC changes, complex technical issues, and recurring product quality trends.
Analytical, QC & Stability
Provide strategic Quality oversight of analytical control strategies supporting biologic and, as applicable, small-molecule components of Aura's products.
Partner with QC leadership to ensure appropriate oversight of release, in-process, stability, characterization, and other analytical testing.
Ensure analytical methods are appropriately developed, transferred, qualified, validated, and maintained throughout the product lifecycle.
Establish governance for specifications, sampling plans, reference standards, stability programs, and analytical lifecycle management.
Provide Quality oversight of significant analytical investigations, OOS/OOT investigations, laboratory deviations, and CAPAs, ensuring timely resolution and appropriate disposition support.
External Manufacturing, Testing & Supplier Quality
Establish strategic Quality governance and risk-based oversight for Aura's external manufacturing, testing, and supplier network.
Provide executive-level oversight of CMOs, contract testing laboratories, critical material suppliers, and other strategic partners.
Establish appropriate Quality Agreements, performance expectations, oversight models, metrics, escalation mechanisms, and governance structures.
Participate in selection, qualification, and ongoing performance management of strategic external partners.
Drive resolution of significant partner Quality issues and ensure critical partners maintain appropriate compliance and inspection readiness.
Partner with Supply Chain and Technical Operations to integrate Quality into sourcing, supply continuity, and manufacturing strategies.
Regulatory, BLA & Inspection Readiness
Provide senior Quality leadership and strategic input into CMC regulatory submissions, including INDs, BLAs, supplements, and applicable global submissions.
Lead Product Quality readiness for BLA submission and commercialization, including identification, prioritization, and remediation of Quality gaps.
Ensure Product Quality strategies and supporting documentation are aligned with regulatory expectations.
Serve as a senior Quality representative during FDA and other health authority inspections and interactions.
Lead Product Quality inspection readiness across Aura and critical external partners, including SME preparedness, mock inspections, documentation readiness, and response governance.
Partner with Regulatory Affairs and CMC on responses to regulatory questions, commitments, observations, and inspection findings, and ensure effective tracking and closure of resulting actions.
Commercial & Launch Readiness
Lead the Product Quality workstream for commercial readiness and launch.
Establish readiness plans, milestones, deliverables, and governance supporting BLA approval and commercial launch.
Ensure the Product Quality organization, systems, processes, suppliers, CMOs, analytical methods, specifications, stability programs, and documentation are ready to support commercial operations.
Partner with Technical Operations and Supply Chain to ensure commercial supply is appropriately supported from a Quality perspective.
Establish the Product Quality framework for post-approval changes, complaints, investigations, CAPAs, product monitoring, and lifecycle management.
Ensure effective transition of Quality responsibilities from development to commercial operations.
Quality Risk Management & Quality Systems
Establish and maintain a robust Product Quality Risk Management framework consistent with ICH Q9(R1).
Ensure significant Product Quality risks are identified, assessed, documented, escalated, and appropriately mitigated.
Develop proactive Quality metrics and risk indicators to identify emerging risks and drive contin

Employment type
Full Time

Work arrangement
No