Quality Systems Management (QMS) Specialist

Position Overview The applicant will be a team player in a small company environment in this highly cross‑functional role. Reporting to the Manager, Quality Management Systems, this person will support the Quality Management System—including quality events, CAPA, continuous improvement, effectiveness checks, and change controls. The primary responsibilities include managing boards, providing guidance to users, preparing reports and metrics, maintaining procedures, supporting process enhancements or releases, and driving on‑time closure of records. This role also supports document management and training systems as required. Accountabilities and Responsibilities Report metrics for change controls, deviations, CAPA, continuous improvement and effectiveness checks. Provide status reports and relevant indicators to department management, and follow up or escale for QMS systems under the scope of responsibility. Support key functional areas by providing guidance on QMS and ensuring consistent application of system practices and regulations. Run QMS board meetings (e.g., Deviations, CAPA, CRB). Lead or support Quality Management System quality projects and continuous improvement initiatives. Assist in process or system enhancements/releases to support the business needs and quality compliance. Support document management and training systems as required. Support internal and external audit/inspection requests for document retrieval. Support the goals and objectives of the Quality organization. Perform other duties as assigned. Education Bachelor’s degree required. Preferred in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy, or related engineering field. Experience 2-4 years of relevant experience in the biotech/pharmaceutical industry. Experience with electronic quality management software is required (Veeva preferred). Expertise in Microsoft Office suite, particularly Outlook, Word, Excel, PowerPoint, and Visio. Skills Working knowledge of QMS systems and requirements for Deviation and Change Management. Ability to interpret GxP requirements. Strong organizational skills and ability to manage and prioritize multiple projects or assignments concurrently, follow through to completion, and meet deadlines. Excellent verbal and written communication skills. Continuous 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 energy, independence, initiative, and self‑motivation, instilling a sense of pace and urgency into the team. Collaborative, creative, willing to take prudent risks, and motivated by transformative treatments for patients and their families. Work Environment The majority of the work is performed in an office environment, though it also involves a laboratory setting. Work may involve common lab hazards; gowning may be required in certain areas. Ability to lift up to 20 pounds for archival tasks is required. 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 may be modified at any time, whether formally or informally. #J-18808-Ljbffr Neurogene Inc.