Dexcom Corporation is hiring a Senior Manager, IT Enterprise Applications to lead and optimize the Quality Organization's portfolio of enterprise applications, with a primary focus on Product Lifecycle Management (PLM). In this remote role, you will drive the strategy, implementation, and continuous improvement of Oracle Cloud PLM, ensuring seamless integration with other critical systems and maintaining compliance with rigorous regulatory standards. You will be part of a company driven by ambitious, passionate people worldwide, aiming to become a leading consumer health technology company.
What You'll Do
- 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.
- Establish business partnerships across the Quality organization and portfolio of Enterprise Systems supporting groups such as Global Customer Advocacy, Global Tech Support, Clinical, and Medical Affairs.
- Partner with external vendors and IT teams to support system maintenance, troubleshooting, and improvements.
What We're Looking For
- 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.
- Experience working in Quality organizations and collaborating with Manufacturing teams.
- Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience.
Nice to Have
- Knowledge of Veeva suite of products supporting Quality, Clinical, Medical Affairs, Vault.
- Knowledge of Smarteeva supporting Customer Advocacy.
- Experience in data migration, system implementation, and change management.
Technical Stack
- Oracle Cloud PLM
- ERP, MES, QMS
- Veeva suite
- Smarteeva
Team & Environment
You will lead and optimize the Quality Organization's portfolio of Enterprise Applications.
Benefits & Compensation
- A front row seat to life changing CGM technology.
- 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.
- Compensation: $141,800.00 - $236,400.00
Work Mode
This is a remote position operating from a home office.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
