Executive Director, Product Quality & Readiness

Aura Biosciences; Boston (MA); On-site; USD 240,000 - 305,000; Full time

Job summary

Aura Biosciences is seeking an Executive Director of Product Quality to serve as the senior operational Quality leader, guiding late-stage development, BLA readiness, and commercial manufacturing readiness. This role partners with Regulatory, Supply Chain, and Therapeutic Operations to embed Quality across the product lifecycle.

The ideal candidate will drive a scalable Quality organization, oversee CMC/analytical activities, and lead inspections and responses with health authorities, ensuring

Qualifications

• Advanced degree in Pharmaceutical Sciences or related field.
• 15+ years of experience in pharmaceutical/biotech Quality, CMC, QC, manufacturing, or related functions.
• Proven senior Quality leadership supporting late-stage development, BLA submission, and commercialization.

Responsibilities

• Provide strategic Quality leadership for Product Quality, CMC, manufacturing, analytical, and external partners.
• Lead readiness for BLA submission, regulatory inspections, and commercialization.
• Oversee external manufacturing, testing partners, supplier quality, and technology transfer.
• Establish governance, risk management, and escalation for Quality issues across the product lifecycle.
• Collaborate with Regulatory Affairs, Supply Chain, and Clinical Development to align Quality with business goals.

Skills

Strategic thinking

Leadership

Cross-functional collaboration

Risk management

Education

MS or PhD in Pharmaceutical Sciences

Job description

Aura Biosciences is seeking an Executive Director of Product Quality to serve as the senior operational Quality leader, guiding late-stage development, BLA readiness, and commercial manufacturing readiness. This role partners with Regulatory, Supply Chain, and Therapeutic Operations to embed Quality across the product lifecycle.

The ideal candidate will drive a scalable Quality organization, oversee CMC/analytical activities, and lead inspections and responses with health authorities, ensuring