Senior Manager, QMS and Document Services

OrganOx 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. OrganOx is a pioneer in normothermic machine perfusion (NMP).  It's 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. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill 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 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 further have responsibility to oversee, configure, 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 OrganOx’ 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 OrganOx’ Quality Management System.

Major Responsibilities

Under direction from the Director, Quality Assurance, the Senior Manager, QMS and Document Services will be responsible for providing strategic leadership, enterprise-wide ownership, and operational excellence of the OrganOx Quality Management System (QMS) and Document Services function.

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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.
• Foster a culture of collaboration, accountability, and continuous learning, aligned with OrganOx’s 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 OrganOx’s 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 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 OrganOx 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 MasterControl-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 in