Manager, Quality Management System (QMS) and Document Services

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The position of Manager QMS & Document Services is responsible for architecture of our Quality Management System and any 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 customer first, be passionate, uphold respect and think boldy, and a commitment to transplantation. The Manager, QMS & Document Services will report directly to the Director, Quality Assurance.

The Manager plays a key leadership role in building organizational 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, 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 totally inclusive and may be augmented by leadership.

This is a flexible, on-site role in our Madison, NJ office to ensure the ongoing Quality and Compliance of OrganOx Quality Management System.

Major Responsibilities

Under direction from the Director, Quality Assurance, the Manager QMS and Document Services will be responsible for:

Leadership & Organizational Capability

• Build, lead, and develop a high-performing global QMS and Document Services team, creating clear pathways for professional growth, capability development, and succession.
• Foster a culture of collaboration, accountability, and continuous learning, aligned with OrganOx’s values of customer first, be passionate, uphold respect and think boldy.
• Act as a visible quality leader across the business, engaging with senior stakeholders to align QMS and Document Services strategy with company objectives.
• Drive organizational capability in document services by developing best practices, training programs, and cross-functional knowledge-sharing.
• Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

QMS & Document Services Excellence

• Lead the architecture, design, and continual improvement of the OrganOx QMS to ensure compliance with all applicable regulatory and quality standards.
• Utilize Product Data Management best practice to ensure compliance with regulatory and quality standards.
• Provide strategic oversight of document management, change control, and MasterControl-based processes, identifying innovative ways to streamline and strengthen compliance.
• Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs.
• Champion the use of quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership.
• Represent the Document Services and QMS functions in Management Review, audits, and inspections, demonstrating leadership and organizational maturity.

Collaboration & Stakeholder Engagement

• Act as a collaborative cross-functional partner, promoting consistent, high-quality practices across global sites.
• 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 organization-wide initiatives to build capability and engagement with quality systems, embedding compliance into daily operations.

Compliance & Risk Management

• Proactively ensure compliance with all relevant international regulations, including US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485.
• 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.

Requirements:
Skills & Experience

• A demonstrated record of success in Quality Management System oversight as demonstrated by successful regulatory audits and inspections.
• An expert-level 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.

Qualifications

• Minimum of a bachelor’s degree in a Life Science, Engineering or Technical subject.
• A minimum of 4 years of document control and change management experience in the Medical Device, Pharmaceutical or other regulated industry is essential.
• Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others is required.
• Experience in effective budget management and resource allocation is highly preferred.
• Strong knowledge of medical device standards and regulations such as: US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485; Knowledge of other relevant regulations and upcoming changes would be advantageous.
• Must have at least one year of experience managing direct report(s).
• Ability to travel internationally up to 10% annually.

#LI-Hybrid

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

Benefits:
The Pay Range for this position is $140,000 - $150,000 annually, with a 20% target annual bonus and 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.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.