Associate Director – Quality Systems and Compliance

Lexeo Therapeutics

Quality Systems & Compliance Associate Director overseeing QMS and training for innovative gene therapies at Lexeo Therapeutics. Leading quality systems aligned with regulatory requirements in biotechnology.

Posted 7/8/2026full-timeNew York City • New York • 🇺🇸 United StatesSenior💰 $176,000 - $189,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing Quality Management Systems (QMS) and electronic Quality Management Systems (eQMS) within regulated environments, ensuring compliance with FDA, EMA, and ICH standards. Proven ability to lead training programs, develop Standard Operating Procedures (SOPs), and foster a culture of continuous improvement.

Highest-signal resume keywords

Quality Management System (QMS) LeadershipElectronic Quality Management System (eQMS) ExpertiseStandard Operating Procedures (SOPs) DevelopmentGxP Training Program ManagementRegulatory Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceDocument ControlQuality Metrics DevelopmentAudit SupportCurriculum Development

Soft Skills

Strategic LeadershipMentoringCollaboration

Tools & Technologies

ZenQMS

Industry Keywords

BiotechnologyPharmaceuticalCell TherapyGene TherapyGxP

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

health insurance
retirement plans
paid time off
flexible work arrangements
professional development