Neurogene Inc. · 3 months ago
Director, GMP Quality Assurance
Houston, TX
Full-time
Onsite
Director/Executive
10+ years expNeurogene Inc. is dedicated to treating devastating neurological diseases through innovative gene therapy solutions. The Director of GMP Quality Assurance will lead the quality systems for manufacturing operations, ensuring compliance with regulatory requirements and overseeing the quality assurance team to support clinical development activities.
Biotechnology
Responsibilities
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
Qualification
Required
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
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
Strong management and organizational skills
Ability to manage and prioritize multiple projects or assignments at one time
Ability to follow assignments through to completion and meet deadlines
Excellent communication (verbal and written) skills
Problem solving skill and ability to make quality decisions based on technical facts and sound risk assessments
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
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
Preferred
Related certifications (ASQ, SQA, ISO)
Company
Neurogene Inc.
Neurogene is accelerating development of new genetic medicines to people with devastating neurological diseases and their families.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$383.5MKey Investors
EcoR1 Capital
2024-11-04Post Ipo Equity· $200M
2020-12-16Series B· $115M
2019-02-12Series A· $68.5M
Leadership Team
Rachel McMinn
Founder & CEO
Julie Choi Jordan
Chief Medical Officer
Recent News
2025-11-15
2025-11-14
MarketScreener
2025-11-14
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