Quality Assurance Manager

JOB TITLE: Quality Assurance Manager

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

SALARY RANGE: $133,000 to $160,000. The midpoint of the range is $138,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION
Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025. Aurion operates as a separate entity with full support from Alcon.

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 Quality Assurance Manager, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States. 

The Quality Assurance Manager is responsible for activities related to Contract Development and Manufacturing Organization (CDMO) oversight, vendor assessment, and Quality Management System (QMS) support.

KEY RESPONSIBILITIES

• Support and manage Quality Systems, including deviations, change control, and CAPA
• Support and maintain vendor management and assessment activities
• Act as QA point of contact on project teams, providing oversight in alignment with regulatory/GMP expectations and established Quality Agreements
• Support quality performance / continuous improvement activities
• Recognize trends in product data and results and work with stakeholders for improvement
• Assess and recommend process improvement measures; then, drive implementation to completion
• Create meaningful metrics for assigned activities; monitor and report on compliance metrics
• Assess product, compliance, or operational risks and develop risk management strategies
• Other duties as assigned

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.

QUALIFICATIONS AND 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 science related field
• 10+ years of cGMP Quality experience
• Experience with performing/participating in risk assessment exercises

REQUIRED SKILLS AND ABILITIES

• Experience working with CDMOs as a client/sponsor preferred
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Demonstrated excellence in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
• Ability to make independent and objective decisions and to work with cross functional teams and partners worldwide
• Experience in auditing/Certified Auditor a plus
• Proficient use of MS Office products