New York Bio Connect
Lexeois building the future of cardiac genetic medicine,andwe’relooking for a bold, strategic leader to help us get there. AsaSenior Directoror Vice President,GxPQuality, you will lead the charge in scaling our Quality organization across clinical andcommercialmanufacturingprograms,embeddingexcellence into every step of our journey from development to commercial launch.You’llarchitect a globally compliant, phase-appropriateGxPstrategy 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 bychallenges,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 clinicalbiomarkers.This individual willbe responsible fordeveloping a phase-appropriate, scalableGxPQuality 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.
Key Responsibilities Quality Leadership & Strategy
Develop and execute a scalableGxPQuality Assurance strategy aligned withLexeo’sbusiness goals and regulatory expectations.
Serve as the senior Quality leader across GMP, GCP, GLP, and GVPfunctions.
Adviseexecutive 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 reflectsLexeo’svalues of scientific rigor and collaboration
Quality Systems Development
Establish andmaintainaphase-appropriateQuality 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
RegulatoryCompliance
Leadand/or provide leadership support forGCP, GLP,GMPand GVPquality activities, includinginternal and external audits, vendor oversight, deviation investigations, and qualityagreements, healthauthority inspections.
Support clinical trial operations by ensuringall aspects of ICH GCP are followed (e.g.,protocoladherence, data integrity, and informed consent compliance)
Overseeearly and late phasemanufacturing 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.
Vendor and Partner Oversight
Oversee and managementof arisk-based vendor qualification programincluding performance of externalaudits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and otherGxPservice 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 scalingGxPquality 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,insupportofCMC 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 withLexeo’sinnovative, 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
$250,000 - $325,000 a year
Compensation is dependent on qualifications and experience.
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.
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Lexeoisseekingan experienced and hands-onseniorleader ofGxPQuality tobe accountable for both leading and operationalizing strategy toscale our Quality organization acrossclinicaldevelopment,manufacturing,translationalsciencesand clinicalbiomarkers.This individual willbe responsible fordeveloping a phase-appropriate, scalableGxPQuality 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.
Key Responsibilities Quality Leadership & Strategy
Develop and execute a scalableGxPQuality Assurance strategy aligned withLexeo’sbusiness goals and regulatory expectations.
Serve as the senior Quality leader across GMP, GCP, GLP, and GVPfunctions.
Adviseexecutive 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 reflectsLexeo’svalues of scientific rigor and collaboration
Quality Systems Development
Establish andmaintainaphase-appropriateQuality 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
RegulatoryCompliance
Leadand/or provide leadership support forGCP, GLP,GMPand GVPquality activities, includinginternal and external audits, vendor oversight, deviation investigations, and qualityagreements, healthauthority inspections.
Support clinical trial operations by ensuringall aspects of ICH GCP are followed (e.g.,protocoladherence, data integrity, and informed consent compliance)
Overseeearly and late phasemanufacturing 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.
Vendor and Partner Oversight
Oversee and managementof arisk-based vendor qualification programincluding performance of externalaudits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and otherGxPservice 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 scalingGxPquality 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,insupportofCMC 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 withLexeo’sinnovative, 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
$250,000 - $325,000 a year
Compensation is dependent on qualifications and experience.
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.
#J-18808-Ljbffr