Associate Director, Quality Systems and Compliance
Job Location:
New York City, NY - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Role Summary
We are seeking an experienced Associate DirectorQualitySystems& Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS) Document Control for Policies SOPs Work Instruction & forms and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements.
The successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems developing and maintaining controlled documentation and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment.
- Provide strategic leadership and operational oversight for the Quality Management System (QMS) Document Control and Training functions
- Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS) ensuring system performance compliance and continuous improvement
- Lead the development review approval implementation and lifecycle management of Standard Operating Procedures (SOPs) work instructions policies and quality records
- Oversee document control processes including document issuance revision control archival and periodic review
- Manage GxP and non-GxP training programs ensuring timely assignment completion effectiveness and compliance with regulatory expectations
- Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement
- Partner with Quality Assurance Regulatory Affairs Manufacturing Technical Operations Clinical Development and other cross-functional teams to ensure quality system effectiveness
- Support internal audits external audits regulatory inspections and supplier audits related to Quality Systems documentation and training
- Ensure Quality Systems remain aligned with FDA EMA ICH and applicable global regulatory requirements
- Lead and mentor Quality Systems personnel fostering a culture of compliance accountability and continuous improvement.
- Bachelors degree in Life Sciences Engineering Quality or a related scientific discipline; advanced degree preferred
- 10 years of Quality Assurance experience within biotechnology pharmaceutical cell therapy or gene therapy industries including progressive leadership responsibilities
- Demonstrated experience managing enterprise Quality Systems in a regulated GxP environment
- Advanced proficiency with eQMS preferably ZenQMS including administration configuration workflow management reporting and user support
- Extensive experience developing revising implementing and managing Standard Operating Procedures (SOPs) and controlled quality documentation
- Demonstrated expertise managing both GxP and non-GxP training programs including curriculum development training assignments compliance monitoring and effectiveness assessments.
- Experience supporting gene therapy cell therapy biologics or other advanced therapeutic products
- Strong understanding of FDA EMA ICH and global GxP regulations
- Experience leading Quality System implementations upgrades or continuous improvement initiatives
- Excellent communication organizational and project management skills
- Proven ability to influence cross-functional stakeholders and lead through change in a fast-paced growing organization
About LEXEO
LexeoTherapeutics 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 Friedreichs Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundationLexeois 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.
Required Experience:
Director
About Company
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 Fr ... View more
