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IT Project Manager

ClifyX, INC

Sunnyvale, CA

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JOB DETAILS
SKILLS
Agile Programming Methodologies, Best Practices, Biology, Budgeting, Change Requests/Orders, Cross-Functional, Document Management, Documentation Plan, FDA (Food and Drug Administration), GxP, ISO (International Organization for Standardization), Information Technology & Information Systems, Leadership, Maintain Compliance, Medical Equipment, Process Development, Product Lifecycle Management, Project Control, Project Planning, Project Schedule, Project/Program Coordination, Project/Program Management, Quality Metrics, Regulations, Regulatory Requirements, Risk Management, System Integration (SI), Team Lead/Manager, Test Requirements, Time Management, Waterfall Model of Software Development
LOCATION
Sunnyvale, CA
POSTED
30+ days ago
Role Summary

Client is seeking an experienced IT Project Manager to lead and deliver Product Lifecycle Management (PLM) initiatives in a regulated ( GxP) environment. The Project Manager will be responsible for end-to-end delivery of PLM projects, coordinating cross-functional teams, managing timelines and risks, and ensuring compliance with applicable quality and regulatory requirements.
This role requires strong hands-on project management skills, experience delivering enterprise PLM solutions, and working knowledge of GxP compliance within life sciences or medical devices.

Key Responsibilities
PLM Project Delivery
  • Lead end-to-end delivery of PLM projects, including planning, execution, monitoring, and closure
  • Manage project scope, schedule, budget, risks, and dependencies across multiple workstreams
  • Drive alignment between business stakeholders, IT teams, vendors, and system integrators
  • Ensure projects are delivered on time, within scope, and to expected quality standards
Stakeholder & Governance Management
  • Act as the primary point of contact for project stakeholders and leadership
  • Facilitate project governance forums, status reviews, and executive updates
  • Proactively manage risks, issues, and change requests using established governance processes
GxP & Compliance Oversight
  • Ensure PLM implementations comply with GxP regulations (e.g., FDA, ISO, CSV principles as applicable)
  • Coordinate with Quality, Validation, and Compliance teams to support validation activities
  • Ensure required documentation (project plans, requirements, test evidence, approvals) is produced and maintained
Delivery & Operational Excellence
  • Apply standard project management methodologies (Agile, Waterfall, Hybrid as applicable)
  • Oversee vendor and partner deliverables to ensure quality and compliance expectations are met
  • Promote best practices for project controls, documentation, and communication

About the Company

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ClifyX, INC

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