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
About LEXEO
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.
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.
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