---
title: 'Associate Director, Quality Systems and Compliance at Lexeo Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-quality-systems-and-compliance-lexeo-therapeutics-new-york-ygjm53j4ddfr'
type: 'job'
last_seen: '2026-09-14'
---

# Associate Director, Quality Systems and Compliance at Lexeo Therapeutics

- **Company:** Lexeo Therapeutics
- **Location:** New York, NY
- **Compensation:** $158k–$207k
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-07-06
- **Last confirmed live:** 2026-09-14
- **Apply:** https://jobs.lever.co/lexeotx/e01c4570-dff6-43e4-8d24-1753d1cd867c

## Job description

## 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 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 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.

## About Lexeo Therapeutics

## Company Overview
- **One-liner**: Lexeo Therapeutics is a clinical-stage genetic medicine company pioneering gene therapies to treat the root causes of inherited cardiovascular diseases and APOE4-associated Alzheimer’s disease.
- **Entity Type**: Public (NYSE: LXEO) – IPO in 2023
- **Headquarters**: New York, New York, United States (345 Park Avenue South, Floor 6)
- **Founded**: 2018
- **Founders**: Ronald Crystal, MD (Founder & Chief Scientific Adviser)

## Core Business
- **Primary industry/industries**: Biotechnology / Genetic Medicine / Gene Therapy
- **Target customers**: B2B (healthcare providers, clinical research institutions, patients via healthcare systems) – focus on larger-rare and prevalent cardiovascular indications with high unmet need.
- **Mission or purpose statement**: “Reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated” (from 10-K) – also “going beyond treating the symptoms of genetic disease by trying to stop its progress at its underlying cause” (from careers page).

## Products & Services
- **LX2006**: Gene therapy candidate for cardiomyopathy associated with Friedreich’s Ataxia (FA). Currently in Phase 1/2 SUNRISE-FA trial; positive interim data reported in 2025/2026. Plans to initiate a registrational study (SUNRISE-FA 2) in H1 2026.
- **LX2020**: Gene therapy candidate for arrhythmogenic cardiomyopathy (ACM) caused by PKP2 mutations. In Phase 1/2 HEROIC-PKP2 trial; positive interim data announced January 2026.
- **Preclinical pipeline**: Additional programs targeting hypertrophic cardiomyopathy, APOE4-associated Alzheimer’s disease, and other genetically defined conditions.

## Market Standing
- **Valuation/Market Cap**: $329.6 million (as of recent data from LinkedIn, 2026)
- **Key Metric**: Annual revenue of $654K (pre-commercial, clinical-stage); total funding not directly disclosed but backed by IPO and institutional investors.
- **Notable Investors/Partners**: Partnerships with Weill Cornell Medicine and University of California San Diego; institutional investors include those common in biotech IPOs (specific names not listed in provided sources).
- **Growth Signals**: 
  - Headcount grew 18.5% YoY to 81 employees (LinkedIn).
  - Positive interim clinical data for both lead programs.
  - FDA feedback expected Q2 2026 for registrational trial design.
  - Expanded pipeline into AI/Data Science for drug discovery (new Sr. Director role posted).

## Competitive Advantages
- **AAVrh10 vector technology**: High transduction efficiency in myocardial cells, lower toxicity potential, and low pre-existing immunity compared to other AAV serotypes.
- **Focus on larger-rare cardiovascular diseases**: Targeting conditions with high unmet need and no approved treatments, enabling a stepwise, capital-efficient development approach.
- **Strong academic partnerships**: Groundbreaking research from Weill Cornell and UCSD provides foundational science and credibility.
- **Full ownership**: Retains exclusive worldwide development and commercialization rights to all product candidates.

## Strategic Focus
- **Late-stage clinical advancement**: Pushing LX2006 and LX2020 toward registrational trials and potential BLA submission.
- **AI and data science integration**: Hiring a Senior Director of AI and Data Science to accelerate decision-making across discovery, development, and operations.
- **Expanding pipeline**: Leveraging early proof-of-concept data to address larger-rare and prevalent indications beyond current lead programs.
- **Manufacturing and CMC**: Scaling up AAV manufacturing processes using Sf9/baculovirus and HEK-based systems.

## Why Work Here
- **Culture**: “Passion to change the arc of medicine” – a mission-driven environment focused on transformative gene therapies.
- **Work model**: Hybrid – 2 days/week in the New York City office, 3 days remote (from careers page).
- **Compensation & benefits**:
  - Competitive salaries (e.g., Director/Sr. Director Clinical Development: $247,500 – $382,000/year)
  - Health, dental, vision, mental health benefits
  - 401(K) with company match, performance bonus, company equity
  - Unlimited PTO, paid holidays, paid parental leave
  - Commuter benefits, tech stipend, stocked kitchen, in-office lunch stipend
  - Life and disability insurance
- **Team**: Led by pioneers in gene therapy and rare disease drug development; small but growing company (81 employees) offering high impact and cross-functional ownership.
- **EEO**: Committed to an exciting, diverse, and enriching work environment.

## Sources
1. [sec.gov](https://www.sec.gov/Archives/edgar/data/1907108/000119312526193939/ars_10-k_2025.pdf) – Form 10-K for FY2025 (filed March 2026)
2. [linkedin.com](https://linkedin.com/company/lexeo-therapeutics) – LinkedIn company page (employees, revenue, market cap)
3. [lexeotx.com](https://www.lexeotx.com/careers/) – Careers page (benefits, culture, hybrid policy, job postings)
4. [jobs.lever.co](https://jobs.lever.co/lexeotx) – Lever job board (open positions)
5. [lexeotx.com](https://www.lexeotx.com/team/) – Leadership team page (founder, executives)

## Other roles at Lexeo Therapeutics

- [Senior Scientist, Process Development (AAV)](https://feeny.ai/job/senior-scientist-process-development-aav-lexeo-therapeutics-new-york-7apz9n3zedj0) — New York, NY
- [Vice President, Medical Affairs](https://feeny.ai/job/vice-president-medical-affairs-lexeo-therapeutics-new-york-rfht2sa2jn1x) — New York, NY
- [Director/Senior Director, Clinical Development](https://feeny.ai/job/director-senior-director-clinical-development-lexeo-therapeutics-new-york-vkywdkr3hqn8) — New York, NY
- [Senior Director, AI and Data Science (Drug Discovery and R&D Enablement)](https://feeny.ai/job/senior-director-ai-and-data-science-drug-discovery-and-r-d-enablement-lexeo-wazq9qsgbtag) — New York, NY