About this opportunity
Opus Genetics lists this Director, Quality Assurance (Gene Therapy Biotech) opportunity in chapel hill, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Director, Quality Assurance - Opus Genetics
Overseeing GxP compliance and quality systems for clinical and CMC activities in AAV gene therapy.
Responsibilities
Lead risk-based QA for clinical development and manufacturing
Maintain and improve Quality Systems
Oversee clinical and supplier quality
Support inspection readiness
Lead investigations and CAPAs
Requirements
Bachelor's in Life Sciences, Pharmacy, or related
10+ years in QA within biotech or pharma
Supporting clinical-stage and CMC/GMP processes
Vendor oversight and regulatory inspections
Skills in GCP, GMP, GxP, Data Integrity, audit management, and risk-based quality management are essential.
Preferred
Advanced degrees or certifications
Experience with eQMS
Experience with biologics or gene therapy programs
High Value
Gene therapy, biologics, clinical and CMC GxP, regulatory inspections, risk management, cross-functional leadership
Durham/remote location, hybrid work
Salary $210K-$225K
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Worksite address
chapel hill, NC, 27517, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.