Senior Manager, Enterprise Applications

🕒 Maio 12

🏄 California – Remoto

🏄 California – Remote

💵 $149.000 - $248.300 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Dexcom

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Wearable Technology

A Dexcom é um dos principais fornecedores de sistemas de monitoramento contínuo de glicose (CGM), revolucionando como as pessoas gerenciam o diabetes e acompanham seus níveis de glicose. Conhecida por sua tecnologia de biossensores de glicose de alta qualidade, a Dexcom oferece produtos como o sistema Dexcom G7 CGM, que fornece monitoramento de glicose em tempo real e insights para ajudar os indivíduos a se tornarem mais saudáveis. Fundada em 1999, a Dexcom tem inovado consistentemente no campo do gerenciamento de diabetes, capacitando os usuários a tomarem controle de sua saúde com soluções precisas e avançadas de monitoramento de glicose. Seus produtos são projetados tanto para adultos quanto para crianças e não exigem receita médica.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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