GxP Quality Lead

Job Description

Job Description

Lexeo is building the future of cardiac genetic medicine, and we’re looking for a bold, strategic leader to help us get there. As a Senior Director or Vice President, GxP Quality, you will lead the charge in scaling our Quality organization across clinical and commercial manufacturing programs, embedding excellence into every step of our journey from development to commercial launch. You’ll architect a globally compliant, phase-appropriate GxP strategy that empowers innovation while ensuring rigor. You’ll shape systems, guide teams, and drive decisions that keep science at the center and quality at the forefront. This is your opportunity to lead with purpose, influence across functions, and build a culture where accountability, collaboration, and continuous improvement thrive. If you’re energized by challenges, inspired by impact, and ready to help set a new standard in genetic medicine, this is your moment.

Lexeo is seeking an experienced and hands-on senior leader of  GxP Quality to be accountable for both leading and operationalizing strategy to scale our Quality organization across clinical development, manufacturing, translational sciences and clinical biomarkers . This individual will be responsible for developing a phase-appropriate, scalable GxP Quality strategy, ensuring compliance with global regulatory standards (e.g., FDA, EMA, ANVISA, ICH), and embedding a culture of operational excellence across the company.

The ideal candidate will bring deep GMP and GCP expertise, strong leadership and communication skills, and the ability to thrive in a fast-paced, development-stage environment while providing strategic oversight and pragmatic solutions that enable innovation.

Key Responsibilities

Quality Leadership & Strategy

• Develop and execute a scalable GxP Quality Assurance strategy aligned with Lexeo’s business goals and regulatory expectations.
• Serve as the senior Quality leader across GMP, GCP, GLP, and GVP functions.
• Advise executive leadership on quality risks, mitigation strategies, and inspection readiness.
• Foster a proactive quality culture rooted in continuous improvement, accountability, and operational excellence.
• Build, mentor, and develop a high-performing Quality team that reflects Lexeo’s values of scientific rigor and collaboration

Quality Systems Development

Regulatory Compliance

Vendor and Partner Oversight

Cross-functional Collaboration

Qualifications

Preferred Experience

Compensation is dependent on qualifications and experience.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.