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Head of Quality Assurance for GMP Operations

2 months ago

Houston, Texas, United States Neurogene Inc. Full time

Company Overview

Neurogene Inc. is dedicated to delivering transformative genetic therapies for patients suffering from rare and severe neurological disorders. Our clinical-stage organization is advancing innovative treatments such as NGN-401 for Rett syndrome and NGN-101 for CLN5 Batten disease, utilizing our proprietary EXACT transgene regulation technology to overcome the challenges of traditional gene therapy in central nervous system conditions. Our state-of-the-art GMP-capable manufacturing facility is fully operational, facilitating vector production from research to clinical-grade and designed for commercial-scale output. Neurogene is publicly traded on the NASDAQ Global Market, and our mission is propelled by a collaborative workforce committed to improving the lives of patients and their families.

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 managing all quality systems associated with Neurogene's manufacturing processes. A comprehensive understanding of phase-appropriate GMP standards is essential, along with the capability to advocate for the Quality System during regulatory evaluations. This role will engage with various departments to support investigational new drug applications and BLA submissions, contributing to the company's evolution from pre-clinical phases to IND enabling studies and 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 phase-appropriate Quality System components and CGMP documentation, such as SOPs, batch records, protocols, and specifications.
  • Serve as the Quality and Compliance Subject Matter Expert for manufacturing operations and support other company functions as necessary.
  • Ensure timely internal audits of manufacturing operations and follow-up on audit CAPAs.
  • Maintain a risk-based supplier quality program appropriate for the clinical development stage.
  • Thoroughly investigate and resolve all non-conformances, OOS, deviations, and complaints.
  • Conduct QA reviews of all manufacturing and QC records, addressing related issues and QA disposition of product batches.
  • Oversee QA review and disposition of raw materials, buffers, and other components.
  • Implement a GMP training program for all personnel involved in CGMP activities at the manufacturing site.
  • Ensure all qualifications, validations, and re-validations for facilities, equipment, methods, and processes are established and maintained.
  • Monitor Quality Systems, including KPI tracking and Quality Risk Management, escalating quality issues to the Executive Director of QA and Executive Team as necessary.
  • Manage relationships and oversee GMP activities conducted by third-party entities.
  • Collaborate with cross-functional teams to ensure timely and high-quality completion of all tasks.
  • Lead continuous improvement initiatives related to the Quality System.
  • Perform additional duties as required.
  • Develop and maintain quality systems and GxP compliance by ensuring all QA team members adhere to established processes and procedures.
  • Address complex challenges by analyzing multiple factors and utilizing data for informed decision-making, exercising sound judgment across a range of situations impacting product, policy, and procedures.

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/pharmaceutical sector, with demonstrated management capabilities.
  • Relevant certifications (ASQ, SQA, ISO) are preferred.
  • Proficient understanding of CGMP requirements for biologics manufacturing and aseptic processes, along with basic knowledge of cell biology and culture.
  • Ability to interpret CGMP requirements and effectively lead teams in a collaborative matrix environment.
  • Strong management and organizational skills, capable of prioritizing multiple projects and meeting deadlines.
  • Excellent verbal and written communication skills, with a strong problem-solving aptitude and ability to make quality decisions based on technical facts and risk assessments.
  • Consistent focus on exceeding expectations in deliverables and performance.
  • Ability to track and measure performance against established metrics.
  • Self-motivated individual with a high level of energy and initiative, capable of instilling urgency within the team.
  • A proactive and decisive individual, passionate about contributing to a company focused on transformative patient treatments.