Clinical Quality Assurance (CQA) Manager

Description: JOB TITLE: Clinical Quality Assurance (CQA) Manager LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, KY, NJ or WA. REPORTS TO: Associate Director, Quality Assurance SALARY RANGE: $133,000 to $160,000 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 Clinical Quality Assurance (CQA) Manager, you will hold an important role in staging Aurion Biotech’s novel cell therapy treatment for successful launch in the United States. The primary purpose of this role is to lead and oversee the CQA strategy in support of clinical study conduct. You will serve as a subject matter expert (SME), ensuring that all clinical development activities are performed in strict accordance with regulatory requirements (FDA, EMA, PMDA), ICH-GCP guidelines, and Aurion’s Quality Management System (QMS). KEY RESPONSIBILITIES

• Strategic Leadership: Serve as the CQA Lead for clinical programs. Set the vision for clinical compliance and ensure quality is integrated into the study design and execution from inception.
• Regulatory Intelligence: Provide expert interpretation of FDA, ICH-GCP, EMA, and other relevant regulatory requirements. Monitor the evolving regulatory landscape to ensure sponsor operations remain compliant and "inspection-ready" at all times.
• Vendor Qualification and Assessment: Strategy and execution of the clinical audit program. This includes qualifying and managing clinical vendors (CROs, central labs) and overseeing a risk-based site audit schedule.
• Inspection Readiness & Support: Serve as the CQA primary point of contact and lead for regulatory inspections (e.g., FDA BIMO).
• Remediation & CAPA Management: Provide strategic guidance on the investigation of significant quality events. Review and approve CAPA plans to ensure effective remediation of systemic GCP issues.
• Clinical Documentation Review: Review and provide final Quality approval for key clinical documents, including Protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), and Trial Master File (TMF) structures.
• Metrics & Reporting: Provide CQA performance metrics and trend analysis to QMS group for Quality Management Reviews (QMR).
• Cross-functional Training: Lead GCP training initiatives for clinical operations and other cross-functional partners to foster a company-wide culture of compliance. 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. Requirements: 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 Biology, Chemistry, or other relevant scientific discipline required.
• Minimum of 8–10 years of experience in the pharmaceutical/biotech industry, with at least 5 years specifically in a GCP Quality Assurance lead role.
• Direct experience with Cell Therapy clinical studies is preferred.
• Proven track record of leading or playing a major role in successful regulatory inspections (FDA/EMA). REQUIRED SKILLS AND ABILITIES
• Expert Knowledge: Deep mastery of 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6 (R2/R3).
• Decision Making: Ability to make complex, risk-based decisions in a fast-paced environment with a sense of urgency.
• Communication: Exceptional verbal and written communication skills, with the ability to influence cross-functional stakeholders and external partners (CROs).
• Vendor Management: Experience managing and auditing large-scale CROs and other Clinical vendors. Apply tot his job

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