Quality Assurance Specialist III GMP Houston

Description 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. 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. Position Overview - Onsite Houston TX 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. Requirements Accountabilities and Responsibilities 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 VY1.1medium 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 requirements, quality systems, and quality expectations. Independently evaluates quality events and operational risks and makes routine to complex quality decisions within established procedures while escalating significant business, regulatory, or product quality risks as appropriate. Supports quality risk assessments and implementation of risk mitigation strategies for manufacturing processes, facilities, systems, and quality system improvements Works closely with cross-functional teams to ensure activities are conducted in compliance with GMP requirements and are completed with a high level of quality, scientific rigor, and timeliness. Responsible for maintaining the company’s controlled documents in accordance with GxP requirements. Other duties as required. Work Schedule Full-time; days. The role will mostly involve standard working hours, but flexibility is required to attend meetings/calls and QA support of production activities. Travel The role may include travel to meet vendors and attend conferences and meetings. Safety The role requires adherence to all company safety policies and procedures. Quality Responsibility Development and maintenance of quality systems and GxP compliance for the business by ensuring that team members comply with processes, procedures and instructions for all activities in which the team participates. Scope Works independently on a wide range of quality assurance activities requiring the evaluation of complex information, interpretation of GMP requirements, and application of sound quality judgment. Analyzes multiple factors, assesses compliance and product quality risks, and determines appropriate actions within established quality systems and procedures. Applies advanced knowledge of GMP regulations, quality systems, manufacturing processes, and industry practices to support operational and quality objectives. Serves as a quality resource for cross-functional teams and provides guidance on quality-related matters, ensuring compliance with internal procedures and regulatory expectations. Exercises considerable judgment in resolving routine and moderately complex quality issues and may lead the investigation and resolution of complex quality events. Identifies compliance risks, recommends solutions, and escalates significant product quality, patient safety, business, or regulatory concerns when appropriate. This role has responsibility for independently managing assigned quality systems, supporting manufacturing and laboratory operations, and driving timely resolution of quality issues. The QA Specialist III works closely with Quality Assurance leadership and cross-functional teams across the organization while providing mentorship and day-to-day guidance to less experienced QA personnel. Expected to contribute to continuous improvement initiatives, inspection readiness activities, and the enhancement of quality systems. Demonstrates increasing leadership, technical expertise, and ownership while serving as a trusted partner to operational teams and helping foster a culture of quality and compliance. Leadership Responsibility The role is to provide support in development and maintenance of quality systems and GxP compliance. The role will involve working closely with the Quality Assurance team, as well as operational teams across the company. Work Environment A majority of the work is done in office, cleanroom and lab environments, with use of a laptop, or in meetings held in a conference room. Eyestrain and/or repetitive motion symptoms may occur due to extensive use of the computer. Education Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field Experience At least 4-6 years of relevant experience in the biotech/pharmaceutical industry Licenses or Certifications GMP and/or Quality certifications a plus Knowledge, Skills & Attributes Strong knowledge of cGMP requirements for biologics manufacturing. Strong knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture. Ability to work collaboratively in matrix organizations and team. Ability to interpret cGMP requirements. Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines. Excellent communication (verbal and written) skills required. Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required. Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results. Ability to track and measure performance against defined metrics. Self-starter with a high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team. Someone who moves fast and decisively in a balanced manner, with a passion for the growing company. Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families. This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally. #J-18808-Ljbffr Neurogene Inc.