Director, Quality Assurance (Gene Therapy Biotech)

Role: Director, Quality Assurance at 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, and lead investigations and CAPAs. Collaborate with cross-functional teams to ensure compliance and risk mitigation. Requirements: Bachelor's in Life Sciences, Pharmacy, or related, with 10+ years in QA within biotech or pharma, supporting clinical-stage and CMC/GMP processes, including vendor oversight and regulatory inspections. Skills in GCP, GMP, GxP, Data Integrity, audit management, and risk-based quality management are essential. Preferred: advanced degrees, certifications, experience with eQMS, and 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.