Description
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 - Houston, TX or remote
This position would oversee the Vendor Management program for all GxP vendors to ensure adherence to regulations, company processes and electronic systems. Ability to work cross functional with Contracts, Finance and Quality to ensure all key requirements tracked, executed and documented
Requirements
Accountabilities and Responsibilities
• Defines and executes a phase-appropriate supplier quality strategy that supports late-stage clinical development and scales to commercial manufacturing in compliance with FDA, EMA, and ICH expectations.
• Manages and coordinates the Vendor Quality Management program and systems (vendor evaluation and selection, vendor qualification, questionnaires, Quality agreements, audit schedules, re-qualification, Vendor Management Boards and vendor risk management)
• Plans, conducts, and oversees supplier audits, including scheduling, execution, reporting, and follow-up of corrective and preventive actions (CAPAs).
• Coordinates and maintains an Approved Vendor List (AVL) for all GxP vendor/services
• Establishes and monitors supplier quality performance metrics (KPIs), conducts periodic performance reviews, and drives continuous improvement initiatives.
• Manages supplier-related quality issues, deviations, complaints, and nonconformances; leads root cause analyses, CAPA development, and effectiveness checks.
• Reviews and approves supplier change notifications, ensures appropriate change control evaluation, and negotiates/maintains quality and technical agreements.
• Supports key functional areas to provide guidance on Audit/SQM electronic modules and ensures consistent application of system practices and regulations.
• Manage Vendor Management Board with key stakeholders to ensure cross functional input and requirements are applied to the vendor.
• Lead or support Quality Management System quality projects and continuous improvement initiatives.
• Lead process or system enhancements/or releases to support the business needs and quality compliance for Audit/SQM module.
• SME for internal and external audit/inspection requests and vendor management program
• Leads, mentors, and develops supplier quality staff; establishes training programs, succession planning, and resource planning to support business growth.
• Supports the goals and objectives of the Quality organization.
• Performs other duties as assigned.
Minimum Requirements
Education
• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, Supply Chain Management or a related scientific discipline is required
• Relevant quality certifications (e.g., ASQ CQA, CQE, RAC) are a plus
Experience
• Minimum 8 years of relevant experience in the biotech/pharmaceutical industry
• Demonstrated experience overseeing GMP and/or GCP suppliers
• Prior people management experience preferred
• Experience with electronic quality management software is required (Veeva is preferred)
• Expertise in Microsoft Office suite of applications, particularly Outlook, Word, Excel, PowerPoint and Visio
Knowledge, Skills & Attributes
• Working knowledge of vendor management systems and familiar with QMS systems
• Ability to interpret GxP 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 completion and meet deadlines.
• Excellent communication (verbal and written) skills are 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 a 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.
Work Environment
• The majority of the work is performed in an office environment
This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally.