Associate Director, Quality Systems and Compliance

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 biotechno logy, 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 eQMS, preferably 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

About LEXEO Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home. LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.