Associate Director, Clinical Quality Assurance

About the Role Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement. Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products. This position is based on-site at our Rockville, Maryland headquarters. Key Responsibilities Quality Systems Leadership Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs. Ensure quality processes and systems meet FDA and global regulatory expectations. Oversee electronic quality systems supporting training management and GxP document control. Clinical Quality Oversight Drive the GCP Quality strategy across clinical development programs. Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements. Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls. Oversee the development and maintenance of Clinical SOPs. Manage training qualification and compliance for Clinical Operations and Data Management teams. Inspection Readiness & Regulatory Support Lead inspection readiness activities across clinical programs. Serve as a lead representative during FDA inspections and vendor audits. Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections. Ensure clinical programs maintain inspection-ready documentation and processes. Risk Management & Continuous Improvement Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies. Identify opportunities for process improvements and quality system enhancements. Ensure quality initiatives and projects are properly resourced and executed within established timelines. Leadership & Team Development Build and lead a high-performing Clinical QA team. Manage hiring, coaching, and development of Quality staff. Promote a culture of quality, compliance, and “first-time-right” execution. Ensure team members maintain appropriate training and qualifications. Operational & Strategic Support Develop and manage Quality department timelines, budgets, and resource planning. Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness. Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers. Qualifications Education Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required Advanced degree (M.S., Ph.D., or equivalent) preferred Experience 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections. 6+ years of leadership experience in Clinical Quality Assurance roles Experience developing, implementing, and maintaining Quality Management Systems (QMS) Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments Experience in cell and gene therapy programs or advanced biologics preferred Core Competencies Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight Ability to maintain independent Quality oversight of Clinical Operations Strong leadership, organizational, and team development skills Excellent written and verbal communication skills Strong problem-solving and risk management capabilities Demonstrated commitment to quality, compliance, and continuous improvement Work Environment & Physical Requirements On-site position with up to approximately 20% travel. Extensive computer and keyboard use involving repetitive motion. Regular telephone and in-person communication. Ability to lift up to 25 pounds, with or without reasonable accommodation. Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law. Why Join Kolon TissueGene? Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients. About Us Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact. Benefits Highlights: Onsite yet Flexible work schedules Premium-free global health insurance (50% dependent coverage) 401(k) with immediate eligibility Long-term incentive bonuses On-site gym & wellness perks Extra PTO accrual every year Global and local training opportunities Visa sponsorship available for qualified candidates Equal Opportunity Employer Kolon TissueGene, 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. Apply today to shape the future of regenerative medicine with precision, rigor, and purpos

Created: 2026-03-16