GxP Quality Lead

Lexeois building the future of cardiac genetic medicine,andwe’relooking for a bold, strategic leader to help us get there. Asa Senior Directoror Vice President,GxPQuality, you will lead the charge in scaling our Quality organization across clinical andcommercialmanufacturingprograms,embedding excellence into every step of our journey from development to commercial launch.

You’ll architect a globally compliant, phase-appropriate

GxPstrategy 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 by challenges,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 clinical biomarkers.

This individual willbe responsible for developing a phase-appropriate, scalable

GxPQuality 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.

• Develop and execute a scalable
  
  GxPQuality Assurance strategy aligned with Lexeo’sbusiness goals and regulatory expectations.
• Serve as the senior Quality leader across GMP, GCP, GLP, and GVPfunctions.
• Advise executive 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 reflects
  
  Lexeo’svalues of scientific rigor and collaboration

• Establish andmaintainaphase-appropriate
  
  Quality Management System (QMS) establishinga document hierarchy including a Quality Manual, policies,SOPsand other documents needed to support a virtual gene therapy organization with early andlatestageprograms.
  
  And, also enabling a QMS that can support a registrational study and commercial launch.
• Ensure quality systems effectively support clinical development,pharmacovigilance,allCMC activities,translational sciences, clinical biomarker development,and external partnerships
• Oversee implementation and maintenance of an electronic QMS (eQMS) to support scalability and compliance

• Leadand/or provide leadership support forGCP, GLP,GMPand GVPquality 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 regulatoryintelligenceanddisseminatethroughout Lexeo.

• Oversee and management of arisk-based vendor qualification program including performance of external audits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and other
  
  GxPservice 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…