Manager, Quality Management Systems

Company Background

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 Manager, Quality Management System is responsible for global management and support of Document Management, Record Management (issuance, archival etc.) and Training. The primary role of this position will be to manage boards, ensure business process oversight of document management, record management and training systems, including guidance to users, reports, metrics, procedures, and drive on time closure of periodic review records.

In addition, identify and support enhancements and/or releases for electronic QMS systems, conduct training, and update relevant procedures. Additional activities included inspection readiness, support for internal audits and inspections as required.

The Manager will also support Quality Management Systems (Change control, Deviations, CAPAs, Continuous Improvements etc.) as required.

The role will assist in management reviews, inspection readiness activities and backroom for inspection. The individual will be a team player able to influence and work cross functional with GXP functions in a small company environment.

Accountabilities and Responsibilities

* Develop and report metrics for Document Management, Record Management and Training Deviations, CAPA, Continuous Improvement and Effectiveness checks. Coordinate the metrics with other key stakeholders (training, document management, supplier quality etc.) to ensure QMS monitoring.

* Manage and support enhancements or releases of the electronic Document management and training systems (Veeva). This includes system requirement setting, execution of UAT, revising procedures, training material creation/updates and roll out.

* Provide status reports, relevant indicators to department management and follow-up and/or escalation for those QMS systems under the scope of responsibility.

* Partner with key functional areas to provide guidance on document management, record management and training to ensure consistent application of system practices and regulations.

* Support various Management Review forums. Includes QMS Board Meetings (e.g. Document Management and Training etc.)

* Support Internal, External Audits and Health Authority Inspections as SME and/or document support for QMS. Support Back-room activities for Health Authority inspections with document request activities or other needed roles.

* Lead or support Quality Management system, Quality projects and continuous improvement initiatives.

* Perform other duties as assigned.

Essential Details - Manufacturing ONLY

Work Schedule

Full time; days. Standard working hours, but flexibility is required to attend meetings and calls.

Travel

5-10%

Safety

Comply with all pertinent safety policies, rules and regulations.

Quality Responsibility

The role will be responsible for developing and maintaining the company's quality systems in compliance with all applicable regulatory requirements, GxP requirements, business processes and regulated electronic system requirements.

Scope

Cross functional to support

Leadership Responsibility

This role will work cross functional to maintain QMS systems and GxP compliance across the company.

Minimum Requirements

Education

* Bachelor's degree in life sciences (Biology, Chemistry, Microbiology, Biochemistry etc.) or related engineering field.

Experience

* 8+ of relevant experience in the biotech/pharmaceutical industry

Licenses or Certifications

* Related certifications (ASQ, SQA, ISO) are preferred but not required.

Knowledge, Skills and Attributes

* Working knowledge of QMS system and regulations for Biopharmaceuticals, Pharmaceuticals or Medical Devices.

* Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.

* Ability to track and measure performance against defined…