Associate Director, Quality Assurance — Remote Cell Therapy

Aurion Biotech Inc.; Massachusetts; Hybrid; USD 176,000 - 204,000; Full time

Job summary

Aurion Biotech Inc. is seeking an Associate Director, Quality Assurance to lead QA oversight of CDMOs and internal teams, ensuring GMP compliance and regulatory readiness for U.S. launch.

You will partner cross-functionally to strengthen quality systems and drive continuous improvement across manufacturing and testing activities. Ideal candidates have 8–10 years in cGMP QA for cell therapy or biologics, plus 5+ years managing QA teams, with hands-on experience in eQMS (ACE/TrackWise) and vendor

Qualifications

• 8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs.
• 5+ years of experience in directly managing a team of direct reports within QA.
• Travel required up to 35%.
• Experience with eQMS (ACE, TrackWise).
• Working knowledge of FDA-regulated biotechnology environment.
• Excellent record-keeping and documentation skills.
• Strong communication skills, both verbal and written.
• Experience working with CDMOs preferred.
• Proficient in MS Office.
• Ability to adapt to changing environments with urgency.

Responsibilities

• Lead QA oversight of CDMO and internal QA activities ensuring regulatory/GMP compliance.
• Support vendor assessment activities and quality management of vendors.
• Oversee data verification and GDP compliance.
• Develop, monitor, and report QA metrics and KPIs for management reviews.
• Review and approve controlled documents and manage change controls.
• Identify risks and implement effective risk management strategies.
• Collaborate cross-functionally to improve quality systems and processes.
• Maintain inspection readiness and drive continuous improvement.

Skills

Travel up to 35%

eQMS experience

FDA-regulated biotech knowledge

Documentation skills

Verbal and written communication

CDMOs experience

MS Office

Adaptability and urgency

Team collaboration

Education

Bachelor’s degree in Biology, Chemistry or related field

Tools

ACE TrackWise

Job description

Aurion Biotech Inc. is seeking an Associate Director, Quality Assurance to lead QA oversight of CDMOs and internal teams, ensuring GMP compliance and regulatory readiness for U.S. launch.

You will partner cross-functionally to strengthen quality systems and drive continuous improvement across manufacturing and testing activities. Ideal candidates have 8–10 years in cGMP QA for cell therapy or biologics, plus 5+ years managing QA teams, with hands-on experience in eQMS (ACE/TrackWise) and vendor