Ass. Director- Analytical Quality Assurance( Cell & Gene Therapy

Ass. Director - Analytical Quality Assurance (Cell & Gene Therapy) About the Role

We are seeking an Associate Director, Analytical QA preferably with prior experience in cell and gene therapy to provide quality oversight for analytical method, testing, and data integrity programs supporting Kolon Tissue Gene’s regenerative cell and gene therapy platform.

Reporting to the Senior Director, Quality Assurance, this role ensures the integrity and regulatory compliance of analytical activities performed both internally and at our CDMO partners.

If you’re an experienced quality professional with a strong analytical background and a passion for scientific excellence, this is your opportunity to help shape the next generation of regenerative medicine quality systems.

Analytical QA Oversight

• Lead QA review and approval of analytical method validation, transfer, and qualification documentation.
• Ensure analytical testing performed at internal labs and CDMOs complies with cGMP, FDA, EMA, and ICH guidelines.
• Review and approve Certificates of Analysis (CoAs), analytical reports, and stability studies supporting batch release and submissions.
• Oversee data integrity (ALCOA+ principles) and ensure analytical data are reliable, traceable, and audit‑ready.
• Provide QA oversight for analytical deviations, CAPAs, and change controls to ensure timely closure and robust root cause analysis.

CDMO & Vendor Quality Management

• Establish and maintain Quality Technical Agreements (QTAs) with analytical and QC service providers.
• Conduct or support audits of CDMOs for analytical, data integrity, and cGMP compliance.
• Provide QA input for analytical method lifecycle activities — validation, transfer, and performance monitoring.

Cross‑Functional Collaboration

• Partner with Analytical R&D, QC, Regulatory Affairs, and Manufacturing to ensure alignment between analytical results, product quality, and regulatory submissions.
• Serve as QA Subject Matter Expert (SME) for analytical processes, data integrity, and inspection readiness.
• Participate in CMC documentation for IND/BLA submissions and support regulatory inspections.
• Implement and maintain QA governance processes to enhance analytical data reliability and compliance.
• Mentor staff and cross‑functional partners in analytical quality principles and data integrity best practices.
• Drive continuous improvement initiatives across analytical QA operations.

Education:

Bachelor’s or advanced degree in Chemistry, Biochemistry, Biology, or related scientific discipline.

Experience:

• Minimum 8 years in Quality or Analytical functions in the biopharma industry.
• At least 3 years in a QA oversight role supporting analytical or QC operations.
• Strong understanding of analytical validation, method transfer, data integrity, and GMP/GLP compliance.
• Experience supporting IND/BLA submissions and regulatory inspections.
• Excellent interpersonal, communication, and organizational skills.

• Onsite yet flexible work schedules
• Premium‑free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long‑term incentive
• On‑site gym & wellness perks
• Extra PTO accrual each year
• Global and local training opportunities

Kolon Tissue Gene, Inc. (KTG) is a clinical‑stage biopharmaceutical company advancing TG‑C, a first‑in‑class cell therapy for osteoarthritis of the knee. Our mission is to redefine regenerative medicine by developing innovative therapies that address the root causes of disease.

As we prepare for our pivotal U.S. launch, we’re building a mission‑driven team dedicated to scientific excellence, compliance, and patient impact.

Kolon Tissue Gene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Ready to ensure the analytical quality behind breakthrough therapies? Apply now and help us shape the future of regenerative medicine.