Sr Manager Enterprise Applications

DexcomSan Diego, CA
Remote

About The Position

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: We are seeking an experienced Senior Manager of IT to lead and optimize our Quality Organization's portfolio of Enterprise Applications. This leader is experienced and adept in solving complex business challenges and finding success in an fluid and some times ambiguous global environment. The candidate will have subject matter expertise and hands-on managing technical teams responsible for Software Quality, Change Control, Configuration Management, Document control, Training, QMS, NCR, CAPA, Audits, writing Quality plans/SOPs, Validation and Verification, Quality Metrics and Software Development. Enterprise Application management experience in Product Lifecycle Management (PLM) processes within the pharmaceutical or medical device industry is required. The ideal candidate will have extensive experience in managing PLM systems, driving digital transformation, and ensuring compliance with industry regulations. This role requires a strategic thinker who can collaborate cross-functionally to enhance product development, data governance, and operational efficiencies.

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.
  • Typically requires a Bachelor’s degree in a technical discipline with 13+ years of industry experience
  • 5-8 years of previous people management experience

Responsibilities

  • 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.

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.
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