Executive Director, Product Quality

Aura Biosciences•Boston, MA

6d•$240,000 - $305,000•Hybrid

About The Position

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.

Requirements

Advanced degree (MS or PhD preferred) in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, Chemistry, Biology, or a related scientific discipline.
15+ years of relevant experience in pharmaceutical or biotechnology Quality, CMC, QC, manufacturing, or related functions, including 8+ years of progressive leadership experience.
Demonstrated success as a senior Quality leader supporting late-stage development, BLA submission, commercialization, and/or product launch.
Extensive experience with biologics and large-molecule products; experience with products involving biologic and small-molecule components highly desirable.
Broad understanding of pharmaceutical Quality across the product lifecycle, including cGMP requirements, applicable ICH guidelines, manufacturing, analytical control strategies, validation, stability, investigations, CAPAs, and Quality Risk Management.
Demonstrated experience with drug substance and drug product manufacturing, technology and site transfers, significant CMC changes, and external manufacturing and testing partners.
Experience supporting BLA submissions and regulatory inspections, preferably including pre-approval inspection readiness.
Demonstrated ability to lead complex cross-functional programs, make sound risk-based decisions, influence senior stakeholders, and build high-performing Quality organizations.
Ability to operate effectively in a fast-paced, entrepreneurial biotechnology environment with evolving priorities.
Ability and willingness to travel domestically and internationally as required.

Nice To Haves

Experience with products involving biologic and small-molecule components highly desirable.
Experience supporting BLA submissions and regulatory inspections, preferably including pre-approval inspection readiness.

Responsibilities

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.
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.
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.
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.
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.
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.
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 continuous improvement.
Partner with the Quality Systems leader to ensure Product Quality processes are appropriately documented, governed, trained, monitored, and incorporated into the global Quality Management System.
Ensure lessons learned from trends, deviations, investigations, inspections, and external partner performance are incorporated into Quality strategy and operational practices.
Build, lead, and develop a high-performing Product Quality organization capable of supporting Aura through BLA approval and commercialization.
Establish the appropriate organizational structure, capabilities, staffing, accountability, and decision rights for Product Quality.
Recruit, develop, mentor, and retain high-caliber Quality professionals and leaders while building succession and organizational depth.
Serve as a trusted senior Quality partner to Technical Operations, CMC, Regulatory Affairs, Supply Chain, Clinical Development, Medical Affairs, and other functions.
Represent Quality in key program governance and business planning forums and influence outcomes across a matrixed organization.
Provide balanced, pragmatic, and risk-based recommendations that appropriately consider patient safety, regulatory compliance, product quality, supply, timelines, cost, and business objectives.
Partner with other Quality leaders to ensure an integrated and cohesive Quality organization.