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
Lexeo Therapeutics is a New York City-based clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease including LX2006 for Friedreich ataxia (FA) LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy and others in devastating diseases with high unmet need.
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 New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the pat ... View more
