Remote QA Associate Director — Quality Leadership

Aurion Biotech; Northern (KY); Hybrid; USD 176,000 - 204,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Parking

Job summary

Aurion Biotech is hiring an Associate Director, Quality Assurance to lead QA oversight of external and internal activities, ensuring GMP compliance and data integrity as the company scales its cell therapy programs.

You will drive continuous improvement of quality systems, oversee vendors, and partner with cross-functional teams to readiness for regulatory submissions and product launches in the United States.

Qualifications

• Bachelor’s degree in Biology, Chemistry or related scientific field.
• 8–10 years of cGMP QA experience in cell therapy or biologics.
• 5+ years of directly managing a QA team.

Responsibilities

• Lead QA oversight of CDMO/CTL activities to meet GMP expectations.
• Ensure data integrity and GDP compliance across QA processes.
• Develop and monitor quality metrics and KPIs for management reviews.
• Support vendor quality activities and risk-based decision making.
• Review and approve controlled documents and quality systems.

Skills

Quality leadership

Cross-functional collaboration

Regulatory knowledge

Documentation

Data integrity

Risk management

Communication

Education

Bachelor’s degree in Biology or Chemistry

Tools

eQMS (ACE/TrackWise)

Job description

Aurion Biotech is hiring an Associate Director, Quality Assurance to lead QA oversight of external and internal activities, ensuring GMP compliance and data integrity as the company scales its cell therapy programs.

You will drive continuous improvement of quality systems, oversee vendors, and partner with cross-functional teams to readiness for regulatory submissions and product launches in the United States.