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.
Where you come in: - 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.
What makes you successful- 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.
What you'll get:- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- 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.
Travel Required: Education Requirements: - Typically requires a Bachelor's degree in a technical discipline with 13+ years of industry experience
- 5-8 years of previous people management experience
Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Salary:
$149,000.00 - $248,300.00
