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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in manufacturing systems management, including strategy, development, and support, with a strong focus on compliance with FDA regulations and validated systems. Proven ability to lead teams, drive automation initiatives, and manage budgets while ensuring seamless integration across operations, quality, and IT.
Highest-signal resume keywords
Manufacturing Systems ManagementGMP/GxP ComplianceMachine Learning for ManufacturingSystem Architecture and IntegrationSix Sigma Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Manufacturing Systems ManagementMachine LearningPredictive MaintenanceSystem ArchitectureLifecycle ManagementAutomationValidation DocumentationChange ControlDigital Factory InitiativesReliability-Centered Maintenance
Soft Skills
LeadershipCommunicationStakeholder ManagementTeam DevelopmentCollaboration
Tools & Technologies
GCPAgentic AIGemini EnterpriseVertix
Certifications & Qualifications
Six Sigma Certification
Industry Keywords
ISO 13485FDA 21 CFR Parts 11FDA 21 CFR Parts 820Electronic Records ComplianceE-Signatures Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead team of experienced professionals in technical design, development and implementation, and lifecycle support for global manufacturing platforms
- Ensure compliance with GMP/GxP, ISO 13485, and FDA 21 CFR Parts 11 and 820
- Drive strategic initiatives including Digital Factory, Reliability-Centered Maintenance, and Manufacturing AI/Analytics
- Drive automation with manufacturing business owners throughout the manufacturing process
- Support full validation documentation and manage validated systems throughout their lifecycle, including periodic reviews, change control, and re-validation
- Participate in testing, release planning, and go-live deployments
- Collaborate with operations, quality, and IT teams to ensure seamless integration and process efficiency
- Contribute to application roadmaps, portfolio planning, budget submissions, and manufacturing and IT strategic plans
- Manage direct reports and support continuous team improvement and development
- Manage the responsible area's budget and provide regular forecast updates
- Work with Manufacturing leadership to support new product introduction, commercial launch, daily operations, and continuous improvement
- Report to the IT Director Manufacturing and Smart Factory
Requirements
What you’ll need- 10+ years of experience in all aspects of manufacturing systems management, including strategy, development, and support
- Experience with Machine Learning, Predictive Maintenance, and AI for Manufacturing
- GCP, Agentic AI, Gemini Enterprise / Vertix strongly preferred
- Proven track record in system architecture, integration, and lifecycle management within regulated environments
- Deep understanding of FDA requirements for validated systems, including GMP/GxP, ISO 13485, FDA 21 CFR Parts 11 and 820, and electronic records/e-signatures compliance
- Excellent leadership, communication, and stakeholder management skills
- Six Sigma experience / certification strongly preferred
- Typically requires a Bachelor’s degree in a technical discipline with 13+ years of industry experience
- 5-8 years of previous people management experience
- Willingness to travel 15-25%
Benefits
Comp & perks- 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
- Home office workplace
- Flex workplace option may be available for employees within commuting distance of a Dexcom site
