Quality Assurance Compliance Manager

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.

Position Overview

The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Director, Quality Assurance (GMP), this person will assist in ensuring GMP compliance and quality oversight supporting product development activities from clinical phase to commercial manufacturing. The applicant must have a strong working knowledge of phase-appropriate GMP requirements, experience in process characterization and validation activities, and familiarity with regulations and guidances specific to gene therapy products. This role will collaborate across the GMP team 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.

Accountabilities and Responsibilities

• Manages the GMP Quality System elements supporting product development activities from clinical phase to commercial manufacturing.
• May manage QA specialists. Considered a team leader, supporting and overseeing activities executed by QA specialists. Hires, trains, coaches and develops staff.
• Develops and ensures implementation of CGMP documentation including, but not limited to, SOPs, Risk Assessments, Study documents supporting Process Characterization and Validation, Product Comparability protocols and reports.
• Acts as Quality and Compliance SME for product development 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 a robust Quality Risk Management process is in place and provides QA oversight and input for risk assessments supporting product development and manufacturing (e.g., product control strategy, potency assurance strategy, GMP facility, etc.).
• Provides QA oversight and participates in the review of regulatory submissions and supporting documentation.
• Acts as Quality Compliance SME for process characterization, process validation, product comparability, and supporting activities, including qualification and validation of facilities, equipment, and methods.
• Acts as Quality Compliance SME for IT Quality, ensuring supporting processes are in place and implemented.
• Monitors relevant regulatory requirements, guidance documents, and industry standards pertaining to Neurogene’s manufacturing and product development processes, interprets compliance requirements, ensures gap analyses are performed against new and revised regulatory requirements, and ensures and supports implementation of changes to Neurogene’s Quality System.
• Ensures GMP training program covers relevant regulatory requirements.
• Participates in monitoring of Quality systems, including tracking of KPIs. Escalates quality issues to management team. Identifies risks and communicates gaps for quality and GMP processes/systems.
• Participates in regulatory inspections and other audits.
• 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.
• Performs other duties as required

Requirements

• 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
• 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 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 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.
• 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.

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.