Quality Assurance Director for GMP Operations

1 week ago

Houston, Texas, United States Neurogene Inc. Full time

Company Overview

Neurogene Inc. is dedicated to developing transformative genetic therapies for patients and families impacted by rare neurological disorders. Our innovative pipeline includes NGN-401 for Rett syndrome and NGN-101 for CLN5 Batten disease, leveraging our proprietary EXACT transgene regulation technology to overcome traditional gene therapy challenges.

Position Summary

We are seeking a collaborative and experienced leader to oversee our Quality Assurance functions within our GMP manufacturing operations. Reporting directly to the Executive Director of Quality Assurance, this role is pivotal in ensuring compliance with regulatory standards and maintaining high-quality systems throughout our manufacturing processes.

Key Responsibilities

  • Lead and manage compliance for a Phase I/II/III/Commercial GMP manufacturing facility.
  • Oversee the GMP Quality Assurance team, including hiring, training, and professional development.
  • Develop, approve, and implement quality system elements and CGMP documentation such as SOPs and batch records.
  • Act as the Subject Matter Expert for quality and compliance in manufacturing operations.
  • Conduct timely internal audits of manufacturing processes and ensure corrective actions are addressed.
  • Maintain a risk-based supplier quality program suitable for clinical development stages.
  • Investigate and resolve non-conformances, deviations, and complaints thoroughly.
  • Ensure quality assurance review of manufacturing and QC records, as well as product batch dispositions.
  • Implement a comprehensive GMP training program for all staff involved in CGMP activities.
  • Oversee qualifications, validations, and re-validations for manufacturing facilities and equipment.
  • Monitor quality systems and track KPIs, escalating issues to the Executive Director and Executive Team as necessary.
  • Manage relationships and oversight of third-party GMP activities.
  • Collaborate with cross-functional teams to ensure high-quality and timely project completion.
  • Drive continuous improvement initiatives within the Quality System.
  • Perform additional duties as required to support quality system development and GxP compliance.

Qualifications

  • Bachelor's degree in life sciences or related engineering field.
  • Over 10 years of experience in pharmaceutical quality systems within the biotech or pharmaceutical industry, with proven management capabilities.
  • Preferred certifications include ASQ, SQA, or ISO.
  • In-depth knowledge of CGMP requirements for biologics and aseptic manufacturing.
  • Strong leadership and organizational skills, with the ability to manage multiple projects effectively.
  • Excellent verbal and written communication skills.
  • Proven problem-solving abilities and sound decision-making skills based on technical data.
  • Self-motivated with a strong sense of urgency and a passion for innovative healthcare solutions.

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