Senior Principal Specialist, QMS
Core
Strategic leadership in the development, governance, and continuous improvement of global Quality Management System (QMS) electronic systems to ensure regulatory compliance and operational efficiency.
Role type
Senior Principal Specialist, QMS eSystems
Builds
Global QMS electronic systems and enterprise system improvement initiatives
Domain
Regulated medical device, pharmaceutical, or biotechnology industry; Quality Management Systems and enterprise digital technologies
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Strategic leadership in QMS eSystems, cross-functional partnership, process gap resolution, system validation, regulatory compliance expertise, audit support, enterprise system governance, lifecycle management
Preferred skills
Global QMS platform experience, IT organization partnership, large-scale enterprise transformation, robotic automation/AI/ML, project management, quality metrics development, change management, GxP knowledge
Technologies
Enterprise Quality Management Systems (QMS), Enterprise Digital Technologies (EDT), Robotic automation, AI, Machine learning
Responsibilities
Lead strategic development and implementation of global QMS electronic systems, partner with Quality and Regulatory Affairs for system enhancements, collaborate on resolving process gaps and integration challenges, document and monitor system interfaces and data flows, drive enterprise system improvement initiatives, manage system activities for validation and project milestones, provide expertise during internal and external audits, develop governance, training, metrics, and reporting
Seniority
Senior Principal, strategic leadership and cross-functional mentorship
