Director, Quality Assurance (Gene Therapy Biotech)

$210k - $225k

Opus Genetics

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 #J-18808-Ljbffr

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