Senior Manager, Enterprise Applications

🕒 il y a 29 jours

🏄 California – Distant

🏄 California – Remote

💵 $149 000 - $248 300 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

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Dexcom

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1999

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Wearable Technology

Dexcom est un fournisseur de premier plan de systèmes de surveillance continue du glucose (CGM), qui révolutionne la façon dont les personnes gèrent le diabète et suivent leur glucose. Reconnue pour sa technologie de biocapteurs de glucose de référence, Dexcom propose des produits tels que le système CGM Dexcom G7, qui offre un suivi du glucose en temps réel et des insights pour aider chacun à améliorer sa santé. Fondée en 1999, Dexcom innove en continu dans le domaine de la prise en charge du diabète, donnant aux utilisateurs les moyens de reprendre le contrôle de leur santé grâce à des solutions de suivi du glucose précises et avancées. Leurs produits sont conçus pour les adultes comme pour les enfants et ne nécessitent pas d’ordonnance.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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