Aurion Biotech · 2 months ago
Director, Product Quality
United States
Full-time
Remote
Director/Executive
$210K/yr - $226K/yr
10+ years expAurion Biotech is a clinical-stage biotech company focused on restoring vision through regenerative therapies. The Director, Product Quality will serve as the strategic and technical quality leader, providing oversight and ensuring quality strategies are integrated across the product lifecycle for cell therapy and cornea care innovation.
BiopharmaBiotechnologyHealth CareMedical
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
Qualification
Required
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
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
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
Preferred
Advanced degree in a relevant scientific or technical field preferred
Experience working with CDMOs strongly preferred
Benefits
We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
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.
Company
Aurion Biotech
Aurion Biotech is a clinical stage biotech company, developing a transformational platform of advanced therapies to cure blindness.
51-200 employees
H1B Sponsorship
Aurion Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$120MKey Investors
Deerfield
2025-03-26Acquired
2022-04-12Series Unknown· $120M
Leadership Team
Greg Kunst
President, Chief Executive Officer, and Board Member
Michael Goldstein
President and Chief Medical Officer
Recent News
2025-10-04
Company data provided by crunchbase