Director, Product Quality

JOB TITLE: Director, Product Quality

LOCATION: Remote candidates based in the following states will be considered: WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, NE, NJ, KY, or MA.

SALARY RANGE: $210,000 to $226,000

ABOUT THE POSITION

This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As the Director, Product Quality, you will serve as the strategic and technical quality leader for Aurion programs. Acting as the primary technical Quality point of contact for drug substance and drug product CMOs, this individual will provide end-to-end quality oversight across the product lifecycle. This role will partner closely with Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, MSAT, Process Sciences, and Analytical and Product Development to ensure quality strategies are integrated into product development, analytical and process characterization, technology transfer, validation, lifecycle management, and commercialization activities.

The ideal candidate combines strong technical depth with regulatory acumen and leadership presence. You will drive proactive quality risk management and operational excellence across Aurion Biotech’s cell therapy portfolio.

KEY RESPONSIBILITIES

• Serve as the end-to-end technical quality expert, providing strategic quality oversight for DS and DP CMOs.
• Develop and implement product quality strategies, including product specifications and justifications, comparability assessments, and control strategies aligned with Quality Target Product Profiles and Critical Quality Attributes.
• Support regulatory submissions, including authoring/reviewing CMC sections and serving as Quality lead for responses to regulatory questions.
• Advise on CMC strategies for commercialization, including in-process controls, comparability, stability, and lifecycle management.
• Provide science- and risk-based evaluation of complex product and process data; develop patient-oriented solutions that integrate safety, quality, and business considerations.
• Lead resolution of major investigations, change controls, and CAPAs that may impact product quality.
• Ensure timely and compliant execution of Product Quality-related activities, including APQRs, specification justifications, and product quality risk assessments.
• Establish and lead the Product Quality Risk Management framework, including risk registers, mitigation tracking, and escalation processes.

QUALIFICATIONS & EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Engineering, or related field).
• 10+ years of experience in the pharmaceutical or biotechnology industry, with experience in MSAT, development, or manufacturing, and at least 5 years in a Quality leadership role supporting late-stage or commercial biologics or cell therapy programs.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Advanced degree in a relevant scientific or technical field preferred.
• Deep understanding of cGMP and international regulatory expectations for biologics and/or cell therapy products.
• Proven experience leading quality oversight for technical transfers, process characterization, process validation, CPV, and product commercialization.
• Demonstrated ability to collaborate effectively across technical and business functions.
• Strong analytical and decision-making skills with the ability to interpret complex datasets and apply sound scientific and regulatory judgement.
• Excellent written and verbal communication skills, including experience with regulatory submissions and health authority engagement. Ability to concisely present information in cross-functional settings.
• Experience working with CDMOs strongly preferred.
• Proficient use of MS Office suite.
• Ability to adapt to a rapidly changing environment while maintaining compliance and urgency.
• Ability to work independently and collaboratively, building trust and alignment across teams.

ABOUT AURION BIOTECH

With offices in Seattle, Boston and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S.We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.