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Neurogene Inc. · 1 month ago

Manager, Quality Management Systems

Houston, TX

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Neurogene Inc. is focused on treating devastating neurological diseases through innovative gene therapy approaches. The Manager, Quality Management Systems will oversee document management, record management, and training systems, ensuring compliance and supporting quality initiatives across the organization.

Biotechnology

Responsibilities

Develop and report metrics for Document Management, Record Management and Training Deviations, CAPA, Continuous Improvement and Effectiveness checks. Coordinate the metrics with other key stakeholders (training, document management, supplier quality etc.) to ensure QMS monitoring

Manage and support enhancements or releases of the electronic Document management and training systems (Veeva). This includes system requirement setting, execution of UAT, revising procedures, training material creation/updates and roll out

Provide status reports, relevant indicators to department management and follow-up and/or escalation for those QMS systems under the scope of responsibility

Partner with key functional areas to provide guidance on document management, record management and training to ensure consistent application of system practices and regulations

Support various Management Review forums. Includes QMS Board Meetings (e.g. Document Management and Training etc.)

Support Internal, External Audits and Health Authority Inspections as SME and/or document support for QMS. Support Back-room activities for Health Authority inspections with document request activities or other needed roles

Lead or support Quality Management system, Quality projects and continuous improvement initiatives

Perform other duties as assigned

Qualification

Quality Management SystemsDocument ManagementRecord ManagementTraining SystemsBiotech Industry ExperienceRegulatory ComplianceContinuous ImprovementVeevaASQ CertificationSQA CertificationISO CertificationPerformance MetricsCollaborationSelf-motivation

Required

Bachelor's degree in life sciences (Biology, Chemistry, Microbiology, Biochemistry etc.) or related engineering field

8+ of relevant experience in the biotech/pharmaceutical industry

Working knowledge of QMS system and regulations for Biopharmaceuticals, Pharmaceuticals or Medical Devices

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 high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency in 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