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Head of Quality Assurance for GMP Operations

2 months ago

Houston, Texas, United States Neurogene Inc. Full time

Company Overview

At Neurogene Inc., we are dedicated to developing transformative genetic therapies for patients and families impacted by rare neurological disorders. Our focus is on advancing clinical-stage products, including NGN-401 for Rett syndrome and NGN-101 for CLN5 Batten disease, utilizing our proprietary technology to enhance gene therapy solutions for central nervous system conditions. Our state-of-the-art GMP-capable manufacturing facility is fully operational, supporting vector production from research through to clinical and commercial-grade outputs. As a publicly traded entity on the NASDAQ Global Market, we are committed to fostering a collaborative culture that prioritizes patient and caregiver perspectives while driving innovation and purposeful problem-solving.

Position Summary

The selected candidate will play a pivotal role in a dynamic, cross-functional environment, reporting directly to the Executive Director of Quality Assurance. This position entails leading and overseeing all quality management systems associated with Neurogene's manufacturing processes. A comprehensive understanding of phase-appropriate GMP regulations is essential, along with the capability to advocate for the Quality System during regulatory reviews. This role will also involve collaboration across various departments to facilitate the submission of investigational new drug applications and biologics license applications, contributing to the company's evolution from pre-clinical to accelerated clinical development.

Key Responsibilities

  • Oversee compliance for a Phase I/II/III/Commercial GMP manufacturing facility.
  • Lead the GMP Quality Assurance team, including hiring, training, and developing staff.
  • Direct the creation, approval, and execution of quality system components and CGMP documentation, such as SOPs and batch records.
  • Act as the subject matter expert for quality and compliance in manufacturing operations, ensuring QA involvement in project teams as necessary.
  • Conduct timely internal audits of manufacturing processes and ensure corrective actions are implemented.
  • Maintain a risk-based supplier quality program suitable for the clinical development stage.
  • Investigate and resolve all non-conformances, deviations, and complaints thoroughly.
  • Ensure QA review of all manufacturing and quality control records, addressing related issues effectively.
  • Manage the QA review and disposition of raw materials and other critical components.
  • Implement a comprehensive GMP training program for all personnel engaged in CGMP activities.
  • Ensure qualifications, validations, and re-validations are completed for all manufacturing-related facilities and equipment.
  • Monitor quality systems, track KPIs, and manage the Quality Risk Management program, escalating issues as needed.
  • Oversee GMP activities conducted by external partners.
  • Collaborate with cross-functional teams to ensure high-quality, timely completion of projects.
  • Lead initiatives for continuous improvement in the Quality System.
  • Perform additional duties as required to support quality system development and GxP compliance.

Qualifications

  • Bachelor's degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy, or a related engineering discipline.
  • Over 10 years of extensive experience in establishing and maintaining compliant Pharmaceutical Quality Systems within the biotech or pharmaceutical sectors, with demonstrated management capabilities.
  • Relevant certifications (ASQ, SQA, ISO) are preferred.
  • In-depth knowledge of CGMP requirements for biologics manufacturing and aseptic processes.
  • Strong ability to interpret CGMP regulations and effectively lead teams in a collaborative environment.
  • Exceptional management and organizational skills, with the ability to prioritize multiple projects and meet deadlines.
  • Excellent verbal and written communication skills, with strong problem-solving abilities.
  • Proactive approach to performance metrics and a commitment to exceeding expectations.
  • Self-motivated with a high level of energy and initiative, capable of instilling urgency within the team.
  • A collaborative and innovative mindset, driven by a passion for developing transformative treatments for patients and their families.