Quality Assurance Specialist III GMP Houston

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile.

The Company's novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile.

The Company's novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Reporting to the Director, Quality Assurance, this position will assist in ensuring GMP compliance and quality oversight for Neurogene's manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development.

The selected individual will be a team player in a small company environment in this highly cross-functional role.

• Performs independent QA review and approval of manufacturing, laboratory, and supporting GMP documentation, ensuring compliance with internal procedures, regulatory requirements, and data integrity expectations.
• Reviews and approves executed batch records, QC testing records, validation documentation, and related GMP records; independently resolves routine and moderately complex documentation issues.
• Leads minor to [VY1.1]medium deviations, investigations, CAPAs, OOS, and change controls; performs thorough root cause analysis, drives cross-functional discussions, and ensures completion of effective corrective and preventive actions.
• Provides QA oversight and decision-making support during manufacturing operations, including room release, line clearance, material movements, product disposition activities, and resolution of in-process quality issues.
• Serves as the primary QA representative for assigned manufacturing processes, facilities, systems, or quality programs, partnering closely with Manufacturing, QC, MSAT, Validation, Engineering, and Supply Chain teams.
• Reviews and approves executed qualification, validation, calibration, maintenance, and commissioning documentation, and executed method qualification and validation documentation, ensuring compliance with GMP requirements and company procedures.
• Provides proactive on-the-floor QA support, identifies compliance risks, and works collaboratively with operational teams to implement timely and effective solutions
• Reviews and approves controlled documents, including SOPs, work instructions, forms, protocols, and reports, ensuring clarity, compliance, and alignment across quality systems.
• Supports regulatory inspections and internal audits by serving as a subject matter resource, providing quality documentation, participating in inspections, and assisting with responses and corrective actions.
• Performs trend analysis of quality system data, identifies systemic issues and compliance risks, and recommends improvements to enhance product quality, inspection readiness, and operational effectiveness.
• Leads or supports continuous improvement initiatives that strengthen quality systems, improve compliance, reduce recurring deviations, and increase operational efficiency
• Provides guidance, coaching, and day-to-day training to QA Specialists I and II and other functional personnel on GMP…