Senior Manager, QMS and Document Services

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 (TSE:4543), founded in 1921, strives to fulfill its mission of "Contributing to Society through Healthcare" by providing solutions in therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The position of Senior Manager QMS & Document Services is responsible for oversight of the architecture of our Quality Management System 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 our ability to reflect our 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 Ox' 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 effective use of it across the business, but also by the strength, resilience, and effectiveness of the team delivering it.

Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not exhaustive and may be augmented by leadership tasks.

This is a flexible on site role at either our Oxford UK site or Giralda Farms New Jersey site in the USA to ensure the ongoing Quality and Compliance of Organ Ox' Quality Management System.

• Leadership & Organisational Capability 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
• Leadership & Organisational Capability Foster a culture of collaboration, accountability, and continuous learning, aligned with Organ Ox's values of Respect, Integrity, Care, Quality and Creativity while acting as a senior quality leader and role model across the organisation
• Leadership & Organisational Capability 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 Ox's Quality Policy
• Leadership & Organisational Capability 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
• Leadership & Organisational Capability Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organisation
• Leadership & Organisational Capability Act as delegated authority to Director, Quality Assurance, including leading during periods of absence and taking accountability for critical quality decisions.

• QMS & Document Services Excellence 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
• QMS & Document Services Excellence 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
• QMS & Document Services Excellence Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs
• QMS & Document Services Excellence Champion develops, define and roll-out relevant quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership
• QMS & Document Services Excellence Lead the Document Services and QMS functions in Management Review, cross functional internal meetings, audits, and inspections, demonstrating leadership and developing organisational…