GxP Quality Lead

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

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

Regulatory 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.

Vendor and Partner Oversight

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

Cross-functional Collaboration

Partner closely with Clinical Development, Regulatory Affairs,…