Lead Dexcom's end-to-end Oracle Cloud PLM strategy, implementation, and continuous improvement efforts across the organization
Manage the integration of PLM with Finance ERP, MES, QMS, and regulatory compliance tools to ensure seamless product data management
Ensure compliance with FDA, ISO 13485, GMP, and other relevant regulatory standards for medical devices and pharmaceuticals
Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and IT teams to standardize and optimize PLM processes
Oversee product data governance, including Bill of Materials (BOM) management, change control, and document control processes
Drive the digital transformation of PLM by implementing best practices, automation, and data analytics
Manage PLM system upgrades, enhancements, and validation in a regulated environment
Train and mentor teams on PLM best practices, system usage, and compliance requirements
Business Partnerships across the Quality organization and portfolio of Enterprise Systems supporting groups such as Global Customer Advocacy, Global Tech Support, Clinical, Medical Affairs
Partner with external vendors and IT teams to support system maintenance, troubleshooting, and improvements.
Requirements
8+ years of experience in PLM management, with a strong background in the pharmaceutical or medical device industry
Hands-on experience with PLM platforms such as Oracle Cloud PLM
Strong understanding of regulatory requirements, validation processes, and compliance standards (FDA, ISO, GMP, GxP, 21 CFR Part 11, etc.)
Experience leading cross-functional teams and managing complex projects in a regulated environment
Knowledge of integrations with ERP, MES, and QMS systems
Knowledge of Veeva suite of products supporting Quality, Clinical, Medical Affairs, Vault
Knowledge of Smarteeva supporting Customer Advocacy
Experience working in Quality organizations and collaborating with Manufacturing teams
Excellent problem-solving, communication, and leadership skills
Experience in data migration, system implementation, and change management.
Tech Stack
Cloud
ERP
Oracle
Vault
Benefits
A full and comprehensive benefits program
Growth opportunities on a global scale
Access to career development through in-house learning programs and/or qualified tuition reimbursement
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve