Associate Director, Quality Systems and Compliance
Lexeo TherapeuticsGene Therapy company
New York, United StatesDirector
D1 Capital Partners
Omega Funds
Eventide Asset Management
Janus Henderson Investors
Longitude Capital
PBM Capital
Operations & Strategy
About the role
TL;DR
Lead quality systems and compliance for innovative gene therapies.
- •Lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control, and Training functions.
- •Key Responsibilities 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.
- •Requirements Bachelor's 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.
Required skills
Compliance Management
Domain expertise
biotech