Senior Director, GCP & GLP QA
RegenxbioUnited States
Posted February 27, 2026
190000 - 330000 USD
Full Time
About the Company
REGENXBIO is a growing company passionate about developing novel AAV gene therapy products to patients.
Job Description
REGENXBIO is seeking a Senior Director, GCP & GLP QA to ensure robust quality assurance systems and procedures are in place to cover pre-clinical activities through clinical trial operations. The successful candidate will have extensive experience conducting and overseeing audits, and will be responsible for ensuring compliance with regulatory requirements and industry standards.
Requirements
- BS in biological science
- Direct job experience in Clinical QA or GLP QA role
- Extensive experience conducting and overseeing audits
- Knowledge of FDA and EU regulations as well as ICH guidelines
- Minimum of 10 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment
- Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company
Benefits
- Market-competitive base salary
- Annual performance-based bonus program
- Stock grants at all levels
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan with 401(k) match
- Summer hours
