Quality Systems Manager/Senior Manager
Core
Own, mature, and modernize scalable Quality Systems for a clinical-stage cell and gene therapy company, ensuring compliance and inspection readiness.
Role type
Senior IC Quality Systems Manager
Builds
Clinical-stage autologous cell therapy programs (e.g., amsoki-cel)
Domain
Biopharmaceuticals / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Quality Management System (QMS) ownership, eQMS implementation, Change Control management, CAPA management, deviation investigation, SOP authoring, regulatory compliance (FDA/ICH/GxP), audit support, process mapping, workflow design, data migration, stakeholder partnership, root cause analysis, risk assessment, executive reporting
Preferred skills
Full eQMS implementation leadership, project management, cross-functional influence without direct authority
Technologies
Veeva, MasterControl, TrackWise
Responsibilities
Manage QMS processes (Change Control, Complaints, Deviations, CAPA, QMR); ensure compliance with FDA/ICH/GxP; author and maintain SOPs and documentation; monitor system performance and drive continuous improvement; support internal/external audits and regulatory inspections; lead eQMS selection, implementation, validation, and optimization; partner with cross-functional teams on requirements and workflows; lead process mapping and change management; manage Change Control program governance; ensure timely and compliant management of quality events; develop quality metrics and executive reporting
Seniority
Senior, hands-on IC