Quality Systems Management (QMS) Specialist

Houston based onsite - must reside locally.

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 which include Quality Events, CAPA, Continuous Improvement, Effectiveness Checks and Change Controls. The primary role of this position will be to manage boards, provide guidance to users, reports, metrics, procedures, support enhancements and/or releases and drive on time closure of records. The role will also support 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, relevant indicators to department management and follow-up and/or escalation for QMS systems under the scope of responsibility.

• Support key functional areas to provide guidance on QMS and ensure consistent application of system practices and regulations.

• Run QMS board meetings (e.g. Deviations, CAPA, CRB, etc)

• Lead or support Quality Management System quality projects and continuous improvement initiatives.

• Assist in process or system enhancements/or releases to support the business needs and quality compliance

• Provide support document management and training system as required.

• Supports internal and external audit/inspection requests for document retrieval

• Supports the goals and objectives of the Quality organization.

• Performs other duties as assigned.

Do you have experience in Visio?, * 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 is preferred)

• Expertise in Microsoft Office suite of applications, particularly Outlook, Word, Excel, PowerPoint and Visio

Knowledge, Skills & Attributes

• Working knowledge of QMS systems and requirements for Deviation and Change Management.

• 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 to completion and meet deadlines.

• Excellent communication (verbal and written) skills 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 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. Ability to lift up to 20 lbs for archival tasks.

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.