Associate Director, Quality Systems and Compliance

Role overview

Lexeo Therapeutics is looking for an accomplished Associate Director of Quality Systems & Compliance to take ownership of the company’s Quality Management System (QMS), document control framework, and training programs. This role will help ensure that the quality infrastructure can support both development and commercialization of advanced gene therapies while staying aligned with global regulatory expectations.

The ideal candidate will be a practical, hands-on quality leader with a strong background in electronic quality systems, controlled documents, and enterprise training administration within biotechnology or pharmaceutical settings.

Key responsibilities

• Set the direction for the Quality Management System, document control, and training operations while also managing day-to-day execution.
• Act as the system owner and subject matter expert for the electronic QMS, with responsibility for system health, compliance, and ongoing improvements.
• Direct the creation, review, approval, rollout, and full lifecycle handling of SOPs, work instructions, policies, and quality records.
• Run document control activities such as release, revision tracking, archiving, and scheduled periodic review.
• Oversee both GxP and non-GxP training processes, including assignment, completion tracking, training effectiveness checks, and compliance with regulatory expectations.
• Create quality dashboards and performance metrics to track system effectiveness and highlight improvement opportunities.
• Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other teams to strengthen quality system performance.
• Assist with internal, external, regulatory, and supplier audits that involve Quality Systems, documentation, and training.
• Keep quality systems aligned with FDA, EMA, ICH, and other applicable global requirements.
• Guide, coach, and develop Quality Systems staff while promoting compliance, ownership, and continuous improvement.

Required experience and qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a closely related scientific field; an advanced degree is preferred.
• At least 10 years of Quality Assurance experience in biotechnology, pharmaceuticals, cell therapy, or gene therapy, with increasing leadership responsibility.
• Proven track record managing enterprise-level quality systems in a regulated GxP setting.
• Strong hands-on experience with ZenQMS, including system administration, configuration, workflow management, reporting, and end-user support.
• Deep experience creating, updating, implementing, and managing SOPs and other controlled quality documents.
• Solid experience running GxP and non-GxP training programs, including curriculum design, training assignment, compliance monitoring, and effectiveness evaluation.

Preferred qualifications

• Background supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products.
• Strong working knowledge of FDA, EMA, ICH, and broader global GxP requirements.
• Experience leading quality system launches, upgrades, or process improvement initiatives.
• Strong communication, organization, and project management abilities.
• Ability to influence cross-functional partners and lead change in a fast-moving, expanding organization.

About Lexeo Therapeutics

Lexeo Therapeutics is a clinical-stage genetic medicine company based in New York City. The company is developing cardiac genetic medicine candidates aimed at addressing the underlying causes of inherited cardiovascular diseases. Its lead program, LX2006, is focused on cardiomyopathy associated with Friedreich’s Ataxia, alongside a broader pipeline targeting genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Supported by a strong financial base, the company is working to bring advanced science into meaningful clinical outcomes.

Work arrangement

This position follows a hybrid setup, with 2 days per week in the New York City office and 3 days working from home.

Equal opportunity and hiring note

Lexeo Therapeutics is an equal opportunity employer committed to building a diverse and enriching workplace.

The company may use artificial intelligence tools during parts of the hiring process, including application review, resume analysis, response assessment, and checks for potential inconsistencies or verification signals. These tools support the recruiting team but do not replace human judgment, and final hiring decisions are made by people. Applicants who want more information about data processing can contact the company directly.