GxP Quality Lead

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, 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 

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