CDMO Outsourced Operations Leader

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.

Requirements:
This vital life cycle management position is US-based (Wisconsin preferred) focused solely on the US market. The Outsourced Operations Leader will manage and develop the relationship with a US-based CDMO (Contract Development and Manufacturing Organization) specifically for the manufacture and continuity of supply of the OrganOx metra® system.

This role may also support the evaluation and development of a second source for the perfusion kit used in the American market.

You will be responsible and accountable for ensuring continuity of supply, supporting local supplier development and risk management, through the development and deployment of improved supplier performance specific to the US market, and definition of supply chain strategies,

Be a change agent

Empowered with the freedom to drive change within the supplier base and expand scope.

Major Responsibilities

Reporting to the Outsourced Operation Manager, the Outsourced Operations Leader will be responsible and accountable for the following:

· Act as the primary point of contact for all CDMO-related activities and issues within the United States.

· Develop and maintain effective relationships with local US suppliers to foster collaboration and trust.

· Be responsible for strategy input and execution for suppliers supporting the American market only.

· Deliver key category performance indicators, including savings, risk mitigation, and quality assurance within the US supply base.

· Supplier selection, onboarding, lifecycle management, and potential management of phase-out specific to the US market, rationalise supplier base,

· Reorganize supply chain.

· Redefine supplier strategy

· Collaborates with suppliers, regulatory and quality team to implement and monitor quality assurance protocols specific to medical devices, ensuring adherence to industry best practices and regulatory requirements.

· Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

· End to end supply chain management of key suppliers including business reviews to manage KPI's

Technical –

• Develop and deploy structured Category Management processes and define supplier management strategies
• Assesses impact and refines category plans to support business requirements.
• Document processes and procedures related to supplier development

· Engages and supports procurement and quality teams to qualify key suppliers & migrate spend from incumbent, poor performance suppliers.

• Develop and deploy supplier performance metrics, to drive continuous improvement and ensure continuity of supply, analyses category supplier performance data to find opportunities for supplier performance improvement establishing continuous improvement goals and deploying adequate projects or activities
• Aligned with the category strategy, collaborate with the Procurement to negotiate supply agreements
• Coordinate Supplier Change control to ensure that any changes in the supply chain do not compromise the quality or compliance of medical devices.
• Manage the OrganOx cross function team to ensure all activities and projects are executed and prioritized to maintain supply continuity

· Coordinates with regulatory affairs to ensure all supplier-related documentation meets the necessary regulatory requirements for medical devices.

Leadership

· Influences cross-functional colleagues (quality, engineering, operations, finance, etc.) to ensure category strategies and activities are aligned with key driver goals, business priorities and financial imperatives

· Works with supplier and leads cross-functional internal teams to advance key business drivers such as supply continuity, quality, cost and operational performance

· Develop supplier strategic partnerships and secures capacity with suppliers (asset management, unconstraint capacity…)

· Collaborates with cross-functional colleagues to unable and support suppliers’ performance.

· Enable team to develop predictive analytics

· Acts as a coach/mentor to colleagues on category strategy process

· Based on business requirements, forecast the category team resources allocation, and animate hiring process.

· Drive stakeholder response to expediate key supplier issues, and drive resolution.

Skills & Experience

· 5+ years of experience in supply chain management, supplier development, procurement, or manufacturing within regulated industry required.

· Proven experience in establishing and managing supplier agreements, contracts, and logistics arrangements

· Strong understanding of medical device manufacturing standards (GMP, ISO 13485, 21 CFR 820, EU MDR) preferred.

· Experience in supplier risk management, escalation handling, and performance tracking required.

· Ability to lead cross-functional teams and drive collaboration between Procurement, Supply Chain, and Quality preferred.

· Strong problem-solving mindset with a proactive approach to supply chain continuity required.

· Good communication skills, including strong written, verbal and data summation abilities.

Qualifications

· Bachelor’s degree or equivalent in a supply chain, operations, manufacturing or related field required.

· Master’s degree preferred.

Lean or Six Sigma process improvement qualifications preferred

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.