Project Manager, Project & Program Management, IT Project Manager

Description

About the company:

Headquartered in Itasca, Illinois, with a satellite location in Belgium, Organ Recovery Systems is a global market-leading provider of organ preservation products and services. We support over 400 transplant programs across 49 countries. In 2025, the company reached 275,000 kidneys perfused with LKT since its launch in 2003. Life Port Kidney Transporter is among a growing family of products and services developed by Organ Recovery Systems to support the Company’s mission of honoring organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.

The Project Manager will lead complex cross-functional initiatives within an FDA-regulated medical device, pharmaceutical, biotechnology, or diagnostics environment. Candidates must have at least 5 years of project and/or program management experience supporting regulated product development, manufacturing, quality, validation, regulatory, or commercialization activities. The ideal candidate has hands-on experience navigating Design Controls, Quality Systems, GMP requirements, Validation processes, and other regulatory requirements that govern product development and commercialization.

This role is responsible for driving project execution from concept through launch, coordinating cross-functional teams, managing project plans, schedules, budgets, risks, and deliverables, and ensuring alignment with business objectives and regulatory expectations. Strong proficiency with project management tools is required, with Smartsheet experience highly preferred. Candidates who have leveraged Smartsheet to build project plans, manage timelines, monitor dependencies, and provide project visibility across stakeholders will be particularly well-suited for this role.

This position requires exceptional communication, organizational, and stakeholder management skills, with the ability to influence cross-functional teams and drive results in a fast-paced, highly regulated environment.

• This role will be responsible for managing assigned company projects, including scheduling and facilitating project team meetings, aligning stakeholders, assigning and tracking action items, monitoring project progress, and driving the team to deliver projects on time, within scope, and within approved budget parameters.
• This role will be responsible for organizing project communication, maintaining project documentation, and coordinating cross-functional project activities to ensure smooth and efficient project execution.
• Create, develop, maintain, and execute plans for organizational projects, including setting targets for milestones and adhering to deadlines while managing projects through the project lifecycle as follows:

• Complete and maintain a Project Plan, including task definition, task sequencing, resource allocation, timeline estimates, potential risks and mitigation plans, dependencies, communication plan, and success criteria for the project.
• Coordinate with project sponsors, department leaders, and functional stakeholders to confirm project scope, objectives, roles, responsibilities, and resource needs.
• Procure and manage adequate project resources to achieve project objectives in planned time frames, escalating resource constraints when necessary.

• Work closely with stakeholders within and outside of the organization to ensure assigned projects are delivered on time and within scope.
• Organize and run project meetings with the appropriate team members to ensure proper understanding of the project initiatives, milestones, timelines, deliverables, risks, decisions, and corresponding responsible parties.
• Assign tasks and responsibilities to appropriate personnel and follow up to ensure timely completion.
• Effectively communicate with superiors, team members, clients, vendors, consultants, and other stakeholders.
• Motivate project team members to meet project goals and maintain accountability for assigned deliverables.
• Manage project scope, schedule, budget, risks, issues, assumptions, dependencies, and change requests.
• Participate in establishing and improving practices, templates, policies, tools, and partnerships that facilitate project success.
• Participate in quality issue resolution and ensure project activities support applicable quality, regulatory, and documentation expectations.
• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation, and excellence.
• Organize project deliverables and supporting documentation, including meeting minutes, action items, decisions, status reports, and related project artifacts, on the appropriate project share drive (Ex. SharePoint, One Drive, etc.).
• Manage the day-to-day project activities and resource coordination for assigned projects.
  
  Provide regular status reporting to the Manager, Program Management Office and project sponsors regarding project…