Role Summary
We are seeking an experienced Associate Director, Quality Systems & Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control for Policies, SOPs, Work Instruction & forms, and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements.
The successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems, developing and maintaining controlled documentation, and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment.
Primary Responsibilities
- Provide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions
- Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement
- Lead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records
- Oversee document control processes, including document issuance, revision control, archival, and periodic review
- Manage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations
- Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement
- Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness
- Support internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training
- Ensure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements
- Lead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement.
Required Skills and Qualifications
- Bachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline; advanced degree preferred
- 10+ years of Quality Assurance experience within biotechnology, pharmaceutical, cell therapy, or gene therapy industries, including progressive leadership responsibilities
- Demonstrated experience managing enterprise Quality Systems in a regulated GxP environment
- Advanced proficiency with ZenQMS, including administration, configuration, workflow management, reporting, and user support
- Extensive experience developing, revising, implementing, and managing Standard Operating Procedures (SOPs) and controlled quality documentation
- Demonstrated expertise managing both GxP and non-GxP training programs, including curriculum development, training assignments, compliance monitoring, and effectiveness assessments.
Preferred Qualifications
- Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products
- Strong understanding of FDA, EMA, ICH, and global GxP regulations
- Experience leading Quality System implementations, upgrades, or continuous improvement initiatives
- Excellent communication, organizational, and project management skills
- Proven ability to influence cross-functional stakeholders and lead through change in a fast-paced, growing organization
Skills Required
- Bachelor's degree in Life Sciences, Engineering, Quality, or related scientific discipline
- Advanced degree
- 10+ years of Quality Assurance experience within biotechnology, pharmaceutical, cell therapy, or gene therapy industries with leadership responsibilities
- Demonstrated experience managing enterprise Quality Management Systems in a regulated GxP environment
- Advanced proficiency with ZenQMS including administration, configuration, workflow management, reporting, and user support
- Extensive experience developing, revising, implementing, and managing SOPs and controlled quality documentation
- Demonstrated expertise managing GxP and non-GxP training programs, including curriculum development and effectiveness assessments
- Experience supporting internal/external audits, regulatory inspections, and supplier audits
- Experience supporting gene therapy, cell therapy, biologics, or advanced therapeutics
- Strong understanding of FDA, EMA, ICH, and global GxP regulations
- Experience leading Quality System implementations, upgrades, or continuous improvement initiatives
- Excellent communication, organizational, and project management skills; ability to influence cross-functional stakeholders
What We Do
LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO’s foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medical College and the University of California, San Diego, two preeminent institutions on the cutting edge of gene therapy research. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases, APOE4-associated Alzheimer’s disease, and CLN2 Batten disease, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. For more information, please visit www.lexeotx.com.
