Director, GMP Quality Assurance

Brief Description

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Position Overview

The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Executive Director, Quality Assurance, this person will be responsible for providing leadership and managing all the quality systems for Neurogene’s manufacturing operations. The applicant must have a strong working knowledge of phase-appropriate GMP requirements and the ability to present and defend the Quality System to regulatory agencies. This role will collaborate across the company and support the filing of investigational new drug applications and BLA submissions 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.

Requirements

• Manages all aspects of compliance for a Phase I/II/III/Commercial GMP manufacturing facility.
• Manages the GMP Quality Assurance team and related GMP quality systems; Hires, trains, coaches and develops staff within the QA team.
• Oversees development, approval and implementation of phase-appropriate Quality System elements and CGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
• Acts as Quality and Compliance SME for manufacturing operations and may be asked to support other functional areas of the company as well. Participates or ensures QA participation in project teams, as required.
• Ensures internal audits are conducted of manufacturing operations on a timely basis; ensures follow-up of audit CAPAs.
• Ensures a risk-based supplier quality program is in place and maintained, appropriate for the stage of clinical development.
• Ensures all non-conformances, OOS, deviations, complaints and related items are thoroughly investigated and resolved in a timely manner.
• Ensures QA review of all manufacturing and QC related records, resolution of all related issues and QA disposition of product batches.
• Ensures QA review and disposition of raw materials, buffers and other components.
• Ensures GMP training program is in place for all staff engaged in CGMP activities at the manufacturing site.
• Ensures all initial qualifications, validations and re-validations are in place for facilities, equipment, methods, and processes related to manufacturing. Ensures facilities are suitable for products manufactured.
• Manages monitoring of Quality Systems, including tracking of KPIs, and Quality Risk Management program. Ensures escalation of quality issues to Executive Director, QA and Executive Team, as appropriate.
• Manages relationships and provides oversight of GMP activities conducted by third parties.
• Works closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner.
• Leads continuous improvement efforts around the design and use of the Quality System.
• Perform other duties as required.
  
  

Requirements:

• Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
• 10+ years of extensive experience in establishing and maintaining compliant Pharmaceutical Quality Systems for the biotech/pharmaceutical industry with proven management experience.
• Related certifications (ASQ, SQA, ISO) preferred
• Working knowledge of CGMP requirements for biologics manufacturing. Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.
• Ability to interpret CGMP requirements. Ability to effectively develop and lead teams and work collaboratively in matrix organizations and team. Must have strong management and organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines. Excellent communication (verbal and written) skills required. Problem solving skill and ability to make quality decisions based on technical facts and sound risk assessments is required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
  
  

Summary

Majority of the work is performed in an office environment however, work is also performed in a lab environment; work may involve common hazards found in a lab environment. In some areas, gowning may be required.