Senior Manager, QMS and Document Services

Overview

Organ Ox is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. Organ Ox is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Terumo Corporation strives to fulfil its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The Senior Manager QMS & Document Services is responsible for oversight of the architecture of Organ

Ox0 Quality Management System (QMS) and all infrastructure elements to affect an efficient and effective QMS, and will oversee, configure, and continually improve our document management, change, and control processes. This role is critical to reflecting Organ

Ox0s core values of Respect, Integrity, Care, Quality and Creativity. The Senior Manager, QMS & Document Services will report directly to the Director, Quality Assurance.

The position plays a key leadership role in building Organ

Ox0 organisational capability; leading, developing, and inspiring a global team; collaborating across functions; and embedding a culture of excellence in quality and compliance. Success in this role will be measured not only by the robustness of the QMS and its effective use across the business, but also by the strength, resilience, and effectiveness of the team delivering it.

• Build, lead, and develop a high-performing global QMS and Document Services team, with explicit accountability for long-term capability building, succession planning and leadership readiness across the function
• Foster a culture of collaboration, accountability, and continuous learning, aligned with Organ
  
  Ox0s values of Respect, Integrity, Care, Quality and Creativity while acting as a senior quality leader and role model across the organisation
• Act as a visible and proactive quality leader across the business, owning the strategic direction of QMS and Document Services and engaging with senior stakeholders to align multi-year QMS strategy with company objectives, the product pipeline, geographic expansion, and Organ
  
  Ox0s Quality Policy
• Drive organisational capability in document services by developing best practices at enterprise level governance, training programs, and state-of-the-art knowledge-sharing across the business
• Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organisation
• Act as delegated authority to the Director, Quality Assurance, including leading during periods of absence and taking accountability for critical quality decisions

• Lead the architecture, design, and continual improvement of the Organ Ox QMS, with end-to-end strategic accountability for system effectiveness, scalability and regulatory readiness ensuring compliance with all applicable regulatory and quality standards
• Provide strategic oversight and governance of document management, change control, and Master Control-based processes, leading major system transformations, upgrades, and harmonisation initiatives to strengthen compliance and operational efficiency
• Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs
• Champion develops, define and roll-out relevant quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership
• Lead the Document Services and QMS functions in Management Review, cross functional internal meetings, audits, and inspections, demonstrating leadership and developing organisational maturity

• Be a role-model as a collaborative cross-functional partner, promoting consistent, high-quality practices across global sites
• Lead team to provide timely and evidence-based communication to the Executive Team, peers, and global colleagues
• Ensure effective budget management and resource allocation in collaboration with the Director, Quality Assurance and other stakeholders
• Lead organisation-wide initiatives to build capability and engagement with quality systems, embedding compliance into daily operations

• Proactively ensure compliance with all relevant international regulations, including US Code of Federal Regulations Title 21 (with emphasis on the pending…