Associate Director, Quality Assurance

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Associate Director, Quality Assurance

Fully Remote
• US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, IN applicants only

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 Associate Director, Quality Assurance, 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 Associate Director, Quality Assurance is responsible for overseeing activities performed by Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL) to ensure compliance against procedures and regulatory submissions and federal requirements. This position will also partner cross-functionally to strengthen quality systems, manage vendor quality activities, support inspection readiness, and foster a culture of quality and continuous improvement.

• Serve as team lead to internal QA team members, leading QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations, and established Quality Agreements
• Support and maintain vendor assessment activities
• Quality management of vendors providing risk-based decision-making during manufacturing and testing activities
• Support quality performance / continuous improvement activities
• Oversee quality of third-party supplier’s services (manufacturing, filling, packaging, shipping as appropriate) and maintain regular oversight via periodic monitoring, auditing, and Quality Agreement reviews
• Manage Data Verification activities to ensure data integrity and compliance with GDP
• Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion
• Develop, monitor, and report meaningful quality metrics and KPIs to support Quality Management Review
• Support Quality systems, including internal and external deviations and change controls
• Assess product, compliance, or operational risks and partner with cross-functional teams to develop and implement effective risk management strategies
• Review and approve controlled documents
• Other duties as assigned

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…