The Role
As the GxP Quality Lead, you will oversee the development and execution of a scalable GxP Quality Assurance strategy, ensuring compliance with global regulatory standards and fostering a proactive quality culture across clinical and commercial programs.
Summary Generated by Built In
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
- 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
- Establish and maintain a phase-appropriate Quality Management System (QMS) establishing a document hierarchy including a Quality Manual, policies, SOPs and other documents needed to support a virtual gene therapy organization with early and late stage programs. And, also enabling a QMS that can support a registrational study and commercial launch.
- Ensure quality systems effectively support clinical development, pharmacovigilance, all CMC activities, translational sciences, clinical biomarker development, and external partnerships
- Oversee implementation and maintenance of an electronic QMS (eQMS) to support scalability and compliance
- Lead and/or provide leadership support for GCP, GLP, GMP and GVP quality activities, including internal and external audits, vendor oversight, deviation investigations, and quality agreements, health authority inspections.
- Support clinical trial operations by ensuring all aspects of ICH GCP are followed (e.g., protocol adherence, data integrity, and informed consent compliance)
- Oversee early and late phase manufacturing QA activities, including batch record review, product release, and disposition in collaboration with CMC and Technical Operations
- Drive inspection readiness and represent Lexeo during regulatory inspections and partner audits
- Establish procedures for surveying regulatory intelligence and disseminate throughout Lexeo.
- Oversee and management of a risk-based vendor qualification program including performance of external audits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and other GxP service providers
- Ensure robust Quality Agreements and alignment of standards and expectations across all external partners
- Partner closely with Clinical Development, Regulatory Affairs, Technical Operations, Supply Chain, and Research to ensure quality is embedded throughout the product lifecycle
- Serve as the QA representative on governance bodies and cross-functional development teams, ensuring risk-based decision-making and clear communication of quality principles
Quality Leadership & Strategy
Quality Systems Development
Regulatory Compliance
Vendor and Partner Oversight
Cross-functional Collaboration
Qualifications
- Bachelor’s degree in a relevant scientific discipline (Biology, Chemistry, Engineering, or related field); advanced degree preferred
- 12–15+ years of experience in Quality Assurance within the biotech or pharmaceutical industry, with significant exposure to both GMP and GCP environments
- Proven leadership in building and scaling GxP quality systems within a clinical- to commercial-stage setting
- Strong knowledge of FDA, EMA, and ICH regulations and inspection practices
- Experience in regulatory submissions, from IND to BLA, in support of CMC and clinical components
- Experience managing audits, CAPAs, deviations, and regulatory inspections
- Demonstrated success leading external partnerships (CROs, CDMOs)
- Excellent communication, collaboration, and problem-solving skills with the ability to influence across functions and levels
- Strategic thinker who can balance regulatory rigor with Lexeo’s innovative, fast-paced biotech environment
Preferred Experience
- Experience with AAV-based gene therapy or biologics
- Familiarity with global clinical trial operations and pharmacovigilance practices
- Proven ability to lead cross-functional quality teams in a growth-stage 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.
Top Skills
Eqms
GCP
Glp
Gmp
Gvp
Gxp
Qms
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The Company
What We Do
LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO’s foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medical College and the University of California, San Diego, two preeminent institutions on the cutting edge of gene therapy research. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases, APOE4-associated Alzheimer’s disease, and CLN2 Batten disease, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization.
For more information, please visit www.lexeotx.com.
