Senior Information Technology Project Manager

Senior PM that speaks Japanese & English
Support Septation related projects
100% Remote (Tokyo, Japan).
Relevant Candidates from anywhere in Japan are authorized to apply for this remote position
Long Term
Key Responsibilities
Lead end-to-end delivery of IT projects within a medical device manufacturing environment, from planning through implementation and stabilization.
Manage project scope, schedule, budget, resources, risks, issues, dependencies, and stakeholder expectations.
Partner with Manufacturing, Quality, Regulatory, Supply Chain, Engineering, Operations, and IT teams.
Manage projects involving ERP, MES, manufacturing applications, quality systems, integrations, infrastructure, and digital transformation initiatives.
Coordinate cross-functional business and technical teams, including internal resources, vendors, consultants, and implementation partners.
Develop and maintain project plans, RAID logs, status reports, executive presentations, and governance documentation.
Facilitate requirements gathering, solution design, testing, validation, deployment, training, and cutover activities.
Ensure IT solutions and project deliverables comply with applicable medical device regulations and quality requirements.
Support Computer System Validation (CSV) activities and ensure proper documentation is completed for regulated systems.
Work closely with Quality and Validation teams on IQ/OQ/PQ, testing, traceability, change control, and system documentation as applicable.
Manage project changes through established change-management and governance processes.
Track project milestones, identify potential delays or risks, and develop mitigation plans.
Lead steering committee and project status meetings with business and IT leadership.
Support manufacturing site implementations, upgrades, integrations, and system rollouts.
Ensure smooth transition from project implementation to production support and operations.
If you find it exciting, please share your updated resume at leo@erp-initiatives.com to discuss further
Contact: 832 787 0822 email: leo@erp-initiatives.com

Work arrangement
Yes