Quality Assurance Specialist III GMP Houston

About the role

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.

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 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 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.
• Maintains the company’s controlled documents in accordance with GxP requirements.

Requirements

• Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field.
• At least 4–6 years of relevant experience in the biotech/pharmaceutical industry.
• GMP and/or Quality certifications a plus.

Skills

• Strong knowledge of cGMP requirements for biologics manufacturing.
• Strong knowledge of requirements for aseptic manufacturing.
• Basic knowledge of cell biology and cell culture.
• Ability to work collaboratively in matrix organizations and teams.
• Ability to interpret cGMP requirements.
• Strong organizational skills with the ability to manage and prioritize multiple projects and meet deadlines.
• Excellent verbal and written communication skills.
• Strong problem-solving skills and ability to make quality decisions based on technical facts and risk assessments.
• Self-starter with a high degree of energy, independence, initiative, and self-motivation.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by transformative treatments for patients and their families.

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.