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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 developing transformative genetic therapies for patients suffering from rare neurological disorders. Our focus is on innovative solutions that leverage our proprietary technology to overcome the challenges faced in conventional gene therapy, particularly for conditions like Rett syndrome and CLN5 Batten disease.

Position Summary

We are seeking a dynamic and experienced professional to lead our Quality Assurance efforts within our GMP manufacturing environment. This pivotal role will report directly to the Executive Director of Quality Assurance and will be instrumental in ensuring compliance with all quality systems related to our manufacturing operations.

Key Responsibilities

  • Oversee compliance for a Phase I/II/III/Commercial GMP manufacturing facility.
  • Lead and develop the GMP Quality Assurance team, including hiring, training, and mentoring staff.
  • Manage the creation, approval, and implementation of quality system documentation and CGMP protocols.
  • Act as the subject matter expert for quality and compliance in manufacturing operations, collaborating with various departments as needed.
  • Conduct timely internal audits of manufacturing processes and ensure effective follow-up on corrective actions.
  • Implement and maintain a risk-based supplier quality program suitable for clinical development stages.
  • Thoroughly investigate and resolve all quality-related issues, including non-conformances and deviations.
  • Ensure QA review of all manufacturing and quality control records, as well as product batch dispositions.
  • Establish and maintain a comprehensive GMP training program for all personnel involved in CGMP activities.
  • Oversee the qualification and validation processes for facilities and equipment used in manufacturing.
  • Monitor quality systems and key performance indicators, escalating issues to the Executive Director as necessary.
  • Manage relationships with third-party vendors conducting GMP activities.
  • Collaborate with cross-functional teams to ensure timely and high-quality project completion.
  • Drive continuous improvement initiatives within the Quality System.

Qualifications

  • Bachelor's degree in life sciences or a related field.
  • Over 10 years of experience in pharmaceutical quality systems, with proven leadership capabilities.
  • Preferred certifications in quality assurance or related fields.
  • Strong understanding of CGMP requirements and aseptic manufacturing processes.
  • Excellent communication and problem-solving skills, with the ability to make informed decisions based on data.
  • Proven ability to manage multiple projects effectively while meeting deadlines.
  • Self-motivated and energetic, with a passion for advancing innovative treatments.

As a key member of Neurogene, you will contribute to a culture that prioritizes patient care and fosters innovation and collaboration.