Senior Manager, QMS and Document Services

OrganOx • Madison, NJ

2d • Onsite

About The Position

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.

Requirements

• A demonstrated record of success in Quality Management System oversight and development as demonstrated by successful regulatory audits and inspections.
• Must have at least 5 years experience of management of eQMS systems and either development, migration or remediation within an eQMS or other document control systems.
• Must have relevant knowledge of Product and Process Data Management with demonstrated success in design and implementation of eQMS or document control systems.
• An expert knowledge of Software-based Quality Management Systems.
• An expert-level knowledge of Document Control and Change Management.
• Demonstrated proficiency in leading and developing successful transaction-based teams.
• Demonstrated ability to lead organization-wide change initiatives and management.
• High level interpersonal skills to both lead a team and to influence the wider organization.
• A minimum of 5 years of experience in a regulated environment, preferably medical devices , is essential.

Nice To Haves

• Knowledge of Japanese PMDA requirements may be an advantage.
• A degree in an engineering, science-related discipline is desirable or demonstrable experience.

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.
• 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.
• 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 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 QMSR), European Union MDR 2017/745, Canadian SOR 98-282, Australian TGA MDR 2002, and ISO 13485. Knowledge of Japanese PMDA requirements may be an advantage.
• Serve as a key contact point during internal and external audits, providing leadership presence and demonstrating system excellence.
• Continuously evaluate compliance risks, implementing robust mitigation and improvement strategies.

Benefits

• We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
• Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility.
• OrganOx supports work-life balance and provides opportunities for ongoing professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees