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Senior Manager, Enterprise Applications

🕒 May 12

🏄 California – Remote

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đŸ’” $149k - $248.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

🩅 H1B Visa Sponsor

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Logo of Dexcom

Dexcom

10,000+ employees

Founded 1999

⚕ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance ‱ Biotechnology ‱ Wearable Technology

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

‱ 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.

đŸ–ïž 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

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