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About the Role

Lead strategic oversight and continuous improvement of the Quality Management System (QMS), Document Control, and GxP/non-GxP Training programs to ensure quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining global regulatory compliance.

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.

Requirements

• 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.
• 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

• ZenQMS administration
• ZenQMS configuration
• ZenQMS workflow management
• ZenQMS reporting
• ZenQMS user support
• SOP development
• Controlled quality documentation management
• GxP training program management
• Non-GxP training program management
• Curriculum development
• Training assignment management
• Compliance monitoring
• Effectiveness assessments
• Gene therapy support
• Cell therapy support
• Biologics support
• Advanced therapeutic products support
• FDA regulations
• EMA regulations
• ICH regulations
• Global GxP regulations
• Quality System implementation
• Quality System upgrades
• Quality System continuous improvement
• Communication skills
• Organizational skills
• Project management skills
• Cross-functional stakeholder influence
• Change leadership

Location

• New York City

Work Type

• Hybrid

Experience Level

• Associate Director
• 10+ years of Quality Assurance experience
• Progressive leadership responsibilities

Education Level

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline
• Advanced degree preferred

Salary/Compensations

• $176,000 - $189,000 a year

About the Company

• 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.

Equal Opportunity

• LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.