Quality Assurance Specialist III GMP Houston

Role: Quality Assurance Specialist supporting GMP compliance and quality oversight in Neurogene’s gene therapy manufacturing operations. Responsibilities: review and approve GMP documentation, lead investigations of deviations, support manufacturing and validation activities, ensure regulatory inspection readiness, and contribute to continuous improvement of quality systems. Collaborates closely with Manufacturing, QC, Validation, and Engineering teams, providing on-the-floor QA support and guidance. Requirements: Bachelor's in life sciences or related field; 4-6 years of biotech/pharma experience; strong knowledge of cGMP biologics manufacturing, aseptic processes, and cell biology; GMP/Quality certifications preferred. High-Value: Focus on biologics, gene therapy, GMP compliance, validation, and manufacturing quality within a clinical-stage biopharma environment transitioning from preclinical to IND-enabling studies. Work setup: onsite Houston, TX; travel as needed.