Senior Manager, Enterprise Applications

This is a fully remote position, open to applicants in California.

📋 Description

• Lead Dexcom's comprehensive Oracle Cloud PLM strategy, implementation, and ongoing enhancement initiatives throughout the organization.

• Oversee the integration of PLM with Finance ERP, MES, QMS, and compliance tools to guarantee seamless management of product data.

• Ensure adherence to FDA, ISO 13485, GMP, and other pertinent regulatory standards applicable to medical devices and pharmaceuticals.

• Collaborate with teams in R&D, Quality, Regulatory Affairs, Manufacturing, and IT to standardize and improve PLM processes.

• Supervise product data governance, which includes Bill of Materials (BOM) management, change control, and document control procedures.

• Propel the digital transformation of PLM by adopting best practices, automation, and data analytics.

• Manage upgrades, enhancements, and validation of the PLM system within a regulated environment.

• Educate and mentor teams on PLM best practices, system utilization, and compliance mandates.

• Foster business partnerships across the Quality organization and a portfolio of Enterprise Systems that support groups such as Global Customer Advocacy, Global Tech Support, Clinical, and Medical Affairs.

• Collaborate with external vendors and IT teams to facilitate system maintenance, troubleshooting, and enhancements.

⛳️ Requirements

• 8+ years of experience in PLM management, particularly in the pharmaceutical or medical device sectors.

• Practical experience with PLM platforms, especially Oracle Cloud PLM.

• Deep understanding of regulatory requirements, validation processes, and compliance standards (FDA, ISO, GMP, GxP, 21 CFR Part 11, etc.).

• Proven experience leading cross-functional teams and managing intricate projects within a regulated setting.

• Familiarity with integrations involving ERP, MES, and QMS systems.

• Knowledge of Veeva products that support Quality, Clinical, Medical Affairs, and Vault.

• Acquainted with Smarteeva, which supports Customer Advocacy.

• Experience in Quality organizations and working collaboratively with Manufacturing teams.

• Strong problem-solving, communication, and leadership capabilities.

• Experience in data migration, system implementation, and change management.

🏝️ Benefits

• A comprehensive and robust benefits program.

• Opportunities for growth on a global scale.

• Access to career development through internal learning programs and/or eligible tuition reimbursement.

• An exciting, innovative organization that leads the industry, dedicated to our employees, customers, and the communities we serve.