GxP Quality Lead

Lexeois building the future of cardiac genetic medicine,andwe’relooking for a bold, strategic leader to help us get there. AsaSenior Directoror Vice President,GxPQuality, you will lead the charge in scaling our Quality organization across clinical andcommercialmanufacturingprograms,embeddingexcellence into every step of our journey from development to commercial launch.You’llarchitect a globally compliant, phase-appropriateGxPstrategy that empowers innovation while ensuring rigor.You’llshape 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. Ifyou’reenergized bychallenges,inspired by impact, and ready to help set a new standard in genetic medicine,this is your moment.

Lexeoisseekingan experienced and hands-onseniorleader ofGxPQuality tobe accountable for both leading and operationalizing strategy toscale our Quality organization acrossclinicaldevelopment,manufacturing,translationalsciencesand clinicalbiomarkers.This individual willbe responsible fordeveloping a phase-appropriate, scalableGxPQuality 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 GCPexpertise, 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 scalableGxPQuality Assurance strategy aligned withLexeo’sbusiness goals and regulatory expectations.
• Serve as the senior Quality leader across GMP, GCP, GLP, and GVPfunctions.
• Adviseexecutive leadership on quality risks, mitigation strategies, andinspectionreadiness.
• Foster a proactive quality culture rooted in continuous improvement, accountability, and operational excellence.
• Build, mentor, and develop a high-performing Quality team that reflectsLexeo’svalues of scientific rigor and collaboration

Quality Systems Development

RegulatoryCompliance

Vendor and Partner Oversight

Cross-functional Collaboration

Qualifications

Preferred Experience

$250,000 - $325,000 a year

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.

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