Executive Director – Product Quality

Aura Biosciences

. Serve as the SVP, Quality's principal operational partner for Product Quality and CMC Quality matters .

Posted 9/15/2026full-timeBrighton • Massachusetts • United StatesLead💰 $240,000 - $305,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Product Quality strategy, CMC Quality, and regulatory compliance, with a strong focus on BLA submission and commercialization. Proven ability to lead high-performing Quality organizations and manage complex cross-functional programs in a fast-paced biotechnology environment.

Highest-signal resume keywords

Product Quality Strategy DevelopmentBLA Submission and CommercializationQuality Risk Management FrameworkLeadership in Pharmaceutical QualityCGMP and ICH Guidelines Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical QualityCMC QualityAnalytical Control StrategiesProcess ValidationQuality Metrics DevelopmentRisk-Based Decision MakingDrug Substance ManufacturingDrug Product ManufacturingRegulatory Inspection ReadinessQuality Oversight

Soft Skills

Cross-Functional LeadershipStakeholder InfluenceTeam BuildingMentoringEffective Communication

Industry Keywords

BiologicsSmall-Molecule ProductsCGMP RequirementsICH GuidelinesQuality ControlQuality AssuranceLifecycle ManagementCAPAStability ProgramsAnalytical Testing

About the role

Key responsibilities & impact

Serve as the SVP, Quality's principal operational partner for Product Quality and CMC Quality matters
Develop and execute Product Quality strategy from late-stage clinical development through BLA submission, approval, commercial launch, and lifecycle management
Establish Product Quality priorities, governance, metrics, and organizational capabilities
Provide strategic Quality input to company, portfolio, CMC, manufacturing, supply, and product development strategies
Identify, assess, and escalate significant Quality risks and provide risk-based recommendations to senior leadership
Provide senior Quality oversight across CMC, drug substance and drug product manufacturing, and product quality activities
Lead Quality activities for manufacturing site selection, qualification, onboarding, technology transfer, site changes, process validation, continued process verification, analytical method transfer and validation, and commercial readiness
Oversee specifications, control strategies, stability, deviations, investigations, CAPAs, changes, and product disposition
Provide strategic oversight of analytical control strategies, release, in-process, stability, characterization, and other analytical testing
Establish governance for specifications, sampling plans, reference standards, stability programs, and analytical lifecycle management
Establish Quality governance and risk-based oversight for external manufacturing, testing, and supplier networks
Provide executive-level oversight of CMOs, contract testing laboratories, critical material suppliers, and strategic partners
Lead Product Quality readiness for BLA submission and commercialization
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
Lead the Product Quality workstream for commercial readiness and launch
Establish readiness plans, milestones, deliverables, and governance supporting BLA approval and commercial launch
Establish the Product Quality framework for post-approval changes, complaints, investigations, CAPAs, product monitoring, and lifecycle management
Establish and maintain a Product Quality Risk Management framework consistent with ICH Q9(R1)
Develop proactive Quality metrics and risk indicators
Build, lead, and develop a high-performing Product Quality organization
Recruit, develop, mentor, and retain Quality professionals and leaders
Serve as a 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

Requirements

What you’ll need

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
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

Benefits

Comp & perks

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