At Neurogene, we focus on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We are using our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. 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.
About the Role
The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Director of Quality Assurance (GMP), this person will manage the Quality Systems to ensure GxP compliance and quality oversight. The applicant must have a strong working knowledge of phase-appropriate GxP requirements and the ability to present and defend the Quality System to regulatory agencies. Familiar with regulations and guidelines of QMS management specific to gene therapy products. This role will collaborate across the company to support the filing of investigational new drug applications and BLA submissions and be part of the company's moving from the pre-clinical stage to the commercial stage.
Responsibilities
- Leads the establishment and maintenance of the company's quality system framework
- May manage QA specialists. Considered a team leader, supporting and overseeing activities executed by QA specialists. Hires, trains, coaches and develops staff.
- Develops, implements, and/or improves quality processes and systems (document management, training, change management, supplier qualification, etc.)
- Manages quality system reviews. Tracks, trends, and analyzes quality system data and information. Summarizes findings and recommends actions and continuous improvement plans.
- Leads the delivery and implementation of new Quality Systems initiatives.
- Manages the supplier qualification program. Participates or leads the assessment, qualification and approval of suppliers, including performing audits.
- Manages the change management program ensuring changes are assessed and implemented per timelines.
- Oversees the training program. Provides “expert” level knowledge and training on Quality System processes. Maintains written procedures for personnel qualification and training and supports the delivery of compliance training sessions.
- Manages the annual product review program.
- Collaborates with internal and external business partners to resolve quality issues by taking risk-based and compliant approaches to solutions
- Supports the goals and objectives of the Quality organization.
- Performs other duties as assigned
Qualifications
- Bachelor's degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field
- 7+ years of relevant experience in the biotech/pharmaceutical industry leading projects/systems/personnel
- Experience with electronic document control and/or training software is required
- Expertise in Microsoft Office suite of applications, particularly Access, Outlook, Word, Excel
- 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, and cell culture.
- Ability to effectively develop and lead teams and work collaboratively in matrix organizations and teams.
- Ability to interpret cGMP requirements.
- Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at the same time, including the ability to follow assignments through to completion and meet deadlines.
- Excellent communication (verbal and written) skills required. Problem-solving skill and the ability to make quality decisions based on technical facts and sound risk assessments is required.