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. Auras 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.

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Position Summary

Aura Biosciences is seeking an experienced strategic and highly collaborative Executive Director Product Quality to serve as the Companys 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 SVPs principal operational partner in the development and execution of Auras 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 Auras transition to a commercial-stage company.

Key Responsibilities

Product Quality Strategy & Leadership

• Serve as the SVP Qualitys 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 Auras 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 Auras 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 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.

Organizational & Cross-Functional Leadership

• 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.

Qualifications

• 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.

Leadership Attributes

The successful candidate will be:

• Strategic and enterprise-minded anticipates future Quality needs while balancing patient safety regulatory expectations business objectives and organizational capability.
• Decisive and pragmatic makes timely well-reasoned decisions and provides clear recommendations to senior leadership.
• Technically credible able to engage effectively with CMC scientific manufacturing regulatory and external partner stakeholders.
• Influential and collaborative drives outcomes across a matrixed organization while maintaining appropriate Quality independence and objectivity.
• Business-oriented understands how to protect patients and compliance while enabling the business to execute.
• People-focused develops strong leaders and builds organizational capability for the future.
• Resilient and adaptable thrives in a rapidly evolving biotechnology environment and effectively represents Quality with health authorities and external partners.

Salary & Benefit Information

Salary Range: $240000/yr - $305000/yr

(Placement within the listed range depends on many factors including but not limited to: geographic location degree years of experience and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Unlimited paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance

Required Experience:

Director