Senior Manager, Product Data Governance & Lifecycle Management
Core
Strategic and operational leadership for product data, configuration management, document control, and PLM systems to ensure data integrity, traceability, and regulatory compliance across the product lifecycle.
Role type
Senior Manager, Product Data Governance & Lifecycle Management
Builds
Compliant and efficient product development, manufacturing, and sustaining operations for medical devices
Domain
Medical Devices / Product Lifecycle Management
Required skills
PLM strategy & roadmap development, governance framework establishment, cross-functional team leadership, regulatory compliance management, process improvement, KPI definition & reporting, system administration, change management
Preferred skills
Oracle Cloud PLM & ERP experience, FDA inspection support, ISO audit support, enterprise process transformation
Technologies
PLM systems, Oracle ERP, CAD
Responsibilities
Lead cross-functional governance forums for product data standards and PLM governance; Establish and maintain governance frameworks for item master data, BOMs, and lifecycle states; Own and improve processes for product data, document control, and engineering changes; Develop and execute PLM strategy aligned with Quality Management System objectives; Monitor best practices and incorporate them into PLM processes; Ensure accuracy and consistency of product data across PLM, ERP, and CAD systems; Establish, monitor, and report KPIs for data quality and compliance; Lead cross-functional initiatives to develop standardized, scalable processes; Ensure compliance with FDA Quality System requirements, ISO 13485, and global regulations; Support internal audits, regulatory inspections, and business initiatives; Lead and develop geographically distributed teams for document control and PLM administration; Lead training, communication, and change management activities; Provide leadership escalation and operational support for complex product data issues.
Seniority
Senior, hands-on IC with management responsibilities
