Manager, Product Transfer Project - CR

25987.5297

Until 9/21/2026 7+ years exp First posted July 23, 2026 Last posted July 23, 2026

Job description

Lead and own the end-to-end transfer of new and existing medical device products across Terumo Neuro sites, including transfers from R&D to manufacturing and between manufacturing facilities. Accountable for the planning, execution, and successful delivery of transfer programs, ensuring compliance with design transfer requirements, regulatory standards (FDA 21 CFR 820, ISO 13485), and internal Quality Management System procedures. Establish and drive transfer governance, including development of transfer agreements, project plans, resource allocation, and risk management to ensure execution aligned with defined scope, timelines, and business objectives. Ensure readiness and completion of all validation and qualification activities (IQ/OQ/PQ), manufacturing documentation, and training required to support a successful production ramp-up. Lead cross-functional and cross-site teams (Engineering, Quality, Supply Chain, Production, and Regulatory) to resolve risks, remove roadblocks, and ensure alignment throughout the transfer lifecycle. Drive operational excellence by ensuring effective planning of materials, equipment, labor, and documentation, while delivering transfer outcomes on time, within budget, and meeting quality and performance targets. Job duties:

Lead and own end-to-end product and process transfers across sites, including new product introductions and sustaining transfers.
Ensure successful execution of design transfer (DHF to DMR) and manufacturing readiness.
Oversee development and verification of specifications, manufacturing processes, tooling, and equipment.
Establish and manage transfer governance framework, including transfer agreements, quality plans, and defined phases, milestone, and tollgates.
Develop and maintain integrated project plans covering scope, timeline, resources, and deliverables.
Proactively identify, assess, and mitigate risks throughout the transfer lifecycle.
Ensure completion of all validation and qualification activities (IQ, OQ, PQ, TMV as applicable). Ensure compliance with FDA 21 CFR 820, ISO 13485, and internal Quality Management System requirements.
Ensure GDP-compliant documentation and audit readiness.
Support or lead investigations and CAPA activities related to transfers.
Apply structured project management methodology (PMI-based preferred).
Scope, schedule, budget, and resource planning.
Maintain and drive project dashboards, RAID logs (Risks, Actions, Issues, Decisions), and executive reporting to leadership.
Ensure readiness for production ramp-up, including materials and supply continuity, equipment readiness, and workforce training and certification.
Accountable for transfer timelines, ramp performance (yield, scrap, efficiency), and cost vs. plan.
Lead cross-functional teams including Engineering, Quality, Supply Chain, and Production.
Lead multi-site transfers (e.g., CR ↔ AV) ensuring alignment and execution discipline.
Drive standardization of transfer processes, KPIs, and best practices.
Champion Lean, Six Sigma, and operational excellence methodologies.
Identify systemic gaps in transfer execution and implement improvements.
Drive adoption of best practices in transfer planning, documentation, and execution.
Lead, coach, and develop direct reports.
Mentor engineers, project managers, and technicians in transfer methodology.
Build organizational capability in transfer execution and project discipline.
Provide clear and structured updates to leadership on transfer progress.
Act as the primary point of contact for stakeholders across sites.
Ensure alignment across functions and timely escalation of risks and issues.
Adhere to QMS requirements and internal procedures.
Demonstrate the highest standards of ethics and integrity.
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
Perform additional duties as assigned.

About this role

Summary

Lead and manage product transfer projects ensuring quality, compliance, and timely delivery.

Job title

Manager, Product Transfer Project - CR

Experience level

senior level

Minimum experience

7+ years exp

Industry

medical devices

Location requirements

Remote work not specified, likely on-site in Japan

Salary

Not specified

Management role

Yes

Skills & keywords

Required skills

project managementregulatory standardsrisk managementvalidation activitiescross-functional leadership

Preferred skills

LeanSix Sigmatransfer governancecost management

Specializations

product transferregulatory complianceproject managementquality assurancemanufacturing

Locations

Structured locations inferred from the posting.

Japan

On-site Country