Director of Operations

About OrganOx:

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Director of Operations North America to join our team.

Position Summary:

The position of Director of Operations is responsible for planning, implementation and management of all aspects of Operations for OrganOx Inc. The core areas Supply Chain Operations, Facilities Management, and Environmental Health & Safety (EH&S) for OrganOx Inc (USA).

The Director of Operations has the following key areas of responsibility:

Define, implement, and maintain the logistics infrastructure required to support customer sales and internal OrganOx Inc operations.

1. Define Operations budget(s),and maintain cost center compliance in accordance with approved budget(s).
2. Hiring, training, and supervision of Supply Chain Operations team, a team that is responsible for procurement, distribution, and inventory control of stock and fixed assets.

Specify, implement, and maintain of Operations Key Performance Indicator (KPI) dashboards specific to OrganOx Inc scope of operation.

Maintain OrganOx Inc Sales and Operational Plan (S&OP) in coordination with SVP Operations OrganOx Limited.

Relationship and regulatory compliance management of OrganOx Inc direct suppliers.

1. Ensure that all OrganOx Inc facilities, both directly managed and sub-contracted, are functioning as required to support OrganOx Inc business operations, including office spaces and functional/operational areas.

Define, implement, and maintain a compliant EH&S management system that encompasses all business activities performed by OrganOx Inc.

Identification and implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective to improve Safety, Quality, Delivery performance, Cost, Employee engagement (SQDCE)

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 the job holder will be expected to complete tasks reasonably requested by the President North America.

Major Responsibilities:

Supply Chain:

• Develop strategy, define business case, present for board approval, and implement a board-approved Supply Chain strategy that delivers resilience at good value to meet the present and future needs of OrganOx Inc. The supply chain strategy will encompass the requirements for customer delivery, customer after sales support, internal business initiatives & objectives, and evolving regulatory compliance landscape.
• Develop, implement, and maintain a Sales and Operational Planning (S&OP) in coordination with OrganOx Limited. The S&OP process is to output an executable supply strategy that meets customer requirements whilst optimizing efficiency and cost of sales.
• Develop, implement, and maintain policies and processes to maintain inventory accuracy, adequate safety stock, and inventory records compliance.
• Develop systems and processes that satisfy OrganOx Inc’s obligations to ISO13485, 21CFRpt820 and 21CFRpt11 with the support and guidance of the Regulatory affairs and Quality Teams.
• Define Supply Chain budget and maintain cost center compliance in accordance with approved budget.
• Define and Budget headcount, hire, train, and supervise the Supply Chain Operations team.

Specify, implement, and maintain of Operations Key Performance Indicator (KPI) dashboards specific to OrganOx Inc Supply Chain scope of operation.

• Manage and monitor the performance of suppliers, manufacturers, and logistics partners using Business Continuity Planning, identify and mitigate risks and issues in the supply chain
• Negotiate supply agreements and annual commercial terms with suppliers and service providers controlled by OrganOx Inc in order to enhance sub-contract KPI performance.

OrganOx Inc Infrastructure:

• Ensure that all OrganOx Inc facilities, both directly managed and sub-contracted, are functioning as required to support OrganOx Inc business operations, including office spaces and functional/operational areas.
• Define, implement, and maintain a compliant EH&S management system that encompasses all business activities performed by OrganOx Inc.
• Develop and maintain procedures that ensure compliance to ISO13485 and 21CFR820 for all Operations tasks/responsibilities that fall under the scope of the OrganOx Quality Management System (QMS).

Leading Change:

• Identification and implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective to improve Safety, Quality, Delivery performance, Cost, Employee engagement (SQDCE)

Required Skills/Abilities

• Excellent communication and interpersonal skills both verbal and written, with a proven track record of business negotiation and report writing.
• The ability to work effectively within, and lead, multi-disciplinary teams.
• The ability to line manage others to help them excel in their roles, realize their potential, and develop their careers.
• The ability to operate in a rapidly changing environment, able to differentiate and prioritize between multiple competing objectives without losing sight of the long-term strategic aims of the company.
• Demonstrable ability to identify and solve problems and justify implementation of improvements through cost-benefit analyses to business performance and cost-basis.
• Demonstrable knowledge of business and management principles as applied to resource allocation, leadership technique, staff and resource coordination, strategic planning, functional cost center and budget management, and human resource modeling.
• Ability to adopt a flexible approach on a day-to-day basis and willingness to perform tasks outside of core job description.

Education and Experience

• Bachelors degree in related field required.
• Masters degree preferred.
• Working knowledge of Occupational Safety and Health Act 1970 preferred.
• OSHA training in “Safety and Health Management”, “Incident Investigation” and “Occupational Safety and Health Standards” preferred.
• Lean Six Sigma experience preferred.
• 7+ years of related experience required.
• Experience working within a fast-growing technology company, preferably in Medical Devices or Pharmaceutical.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Able to travel at short notice to any global location (primarily USA).
• Physical Demands: While performing the duties of this job, the employee is regularly required to talk, hear, and speak. The position may require sitting for significant periods of the day while working on the computer. The employee must occasionally lift or move items weighing up to 50 pounds.

Other Qualifications:

• Work Environment: This is a hybrid working role is based from OrganOx Inc headquarters office in Madison, New Jersey.
• Work Accessibility: Unless travelling attendance to the OrganOx Inc office is expected 3 days per week. Must live within an hour commute of a major airport.

WHAT WE OFFER

Our team is dynamic and motivated as we strive to achieve excellence in the field of organ transplantation. We seek to recruit and retain the best people from a broad range of backgrounds who share our values of innovation, evidence, integrity, teamwork, respect and passion. We offer competitive compensation and excellent benefits packages to our employees in an effort to safeguard your health, to ensure your work-life balance, and to provide you with ongoing financial stability.

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.