Kolon TissueGene, Inc. · 5 days ago
Ass. Director- Analytical Quality Assurance( Cell & Gene Therapy)
Rockville, MD
Full-time
Onsite
Director/Executive
8+ years expKolon TissueGene, Inc. is a clinical-stage biopharmaceutical company advancing innovative therapies in regenerative medicine. The Associate Director of Analytical QA will provide quality oversight for analytical methods and ensure regulatory compliance for analytical activities, while collaborating with cross-functional teams to support product quality and regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceutical
Hiring Manager
Vaidehi Hussain
Responsibilities
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
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
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
Qualification
Required
Bachelor's or advanced degree in Chemistry, Biochemistry, Biology, or related scientific discipline
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
Preferred
Prior experience in cell and gene therapy
Benefits
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
Visa sponsorship available for qualified candidates
Company
Kolon TissueGene, Inc.
Kolon TissueGene, Inc. is a biotechnology company developing advanced cell therapies to target various orthopedic diseases and degenerative disorders.
11-50 employees
H1B Sponsorship
Kolon TissueGene, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$124.73M2024-06-05Post Ipo Equity· $35M
2023-05-15Post Ipo Equity· $30M
2022-08-26Post Ipo Equity· $29.64M
Leadership Team
Sun Jin Kim
Chief Medical Officer
Recent News
2025-02-16
Company data provided by crunchbase