GxP Quality Lead

Base pay range

$/yr - $/yr

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.

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) with 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, 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, quality agreements, and 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 disseminating throughout Lexeo.

Vendor and Partner Oversight

• Oversee and manage 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, 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.

• 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…