Senior Project Manager

Senior Project Manager

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. LifePort 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.

POSITION SUMMARY:

The Senior Project Manager will lead complex, cross-functional, and strategic initiatives within an FDA-regulated medical device, pharmaceutical, biotechnology, or diagnostics environment. Candidates must have at least 10 years of project and/or program management experience supporting regulated product development, manufacturing, quality, validation, regulatory, or commercialization activities. The ideal candidate has significant experience navigating Design Controls, Quality Systems, GMP requirements, Validation processes, Regulatory Compliance, and other requirements that govern the development, manufacture, and commercialization of regulated products.

This role is responsible for providing project leadership, governance, executive-level communication, stakeholder alignment, risk management, and delivery oversight for high-impact programs that support critical business objectives. The Senior Project Manager will drive project execution from concept through commercialization, coordinate cross-functional teams, and ensure projects remain on track with respect to scope, schedule, budget, quality, and regulatory expectations.

Strong proficiency with project management tools is required, with Smartsheet experience highly preferred. Candidates who have leveraged Smartsheet to build and manage complex project plans, executive dashboards, resource tracking, reporting, workflow automation, and portfolio visibility will be particularly well-suited for this role.

This position requires exceptional communication, leadership, and influence skills, with the ability to effectively engage executive stakeholders, facilitate decision-making, and drive successful outcomes across multiple functions in a fast-paced, highly regulated environment.

SUPERVISORY RESPONSIBILITIES:

May provide work direction, mentoring, and coaching to Associate Project Managers, Project Managers, and project team members as assigned.

PRIMARY (ESSENTIAL) FUNCTIONS:

• This role will be responsible for leading complex company projects and programs, including establishing project structure, facilitating executive and cross-functional alignment, managing project teams, tracking progress, resolving escalated issues, and ensuring delivery of strategic initiatives on time, within scope, and within approved budget parameters.
• This role will be responsible for supporting PMO governance, portfolio visibility, project reporting discipline, and continuous improvement of project management practices across the organization.
• Create, develop, maintain, and execute plans for complex organizational projects and programs, including setting targets for milestones and adhering to deadlines while leading projects through the project lifecycle as follows:

Project Kickoff/Planning

• Complete and maintain comprehensive Project Plans, including scope, objectives, business requirements, task definition, task sequencing, resource allocation, timeline estimates, budget considerations, risks, mitigation plans, dependencies, governance structure, communication plan, and success criteria for the project or program.
• Partner with executive sponsors, business leaders, department heads, vendors, and functional stakeholders to establish project objectives, roles, responsibilities, decision rights, and escalation paths.
• Develop project governance, stakeholder engagement plans, status reporting cadence, and steering committee materials, as applicable.
• Procure, coordinate, and manage adequate project resources to achieve project objectives in planned timeframes, escalating resource, budget, or priority conflicts when necessary.

Project Execution

• Lead complex projects and programs in collaboration with stakeholders within and outside of the organization to ensure delivery on time and within scope.
• Organize and lead project meetings, steering committee discussions, and stakeholder reviews to ensure proper understanding of project initiatives, milestones, timelines, deliverables, risks, decisions, and corresponding responsible parties.
• Assign tasks and responsibilities to appropriate personnel and provide work direction to support timely completion of deliverables.
• Effectively communicate with executives, superiors, team members, clients, vendors, consultants, and other stakeholders.
• Motivate project team members, remove barriers, and drive accountability for project goals and deliverables.
• Manage project scope, schedule, budget, resources, risks, issues, assumptions, dependencies, change requests, and business impacts.
• Establish and improve practices, templates, policies, tools, and partnerships that facilitate project success and strengthen PMO maturity.
• Lead or support 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, steering committee materials, risk logs, issue logs, and related project artifacts, on the appropriate project share drive (Ex. SharePoint, OneDrive, etc.).
• Manage day-to-day project and program activities, resource coordination, and stakeholder alignment for assigned complex initiatives.
• Provide executive-ready status reporting to the Manager, Program Management Office, project sponsors, and leadership regarding project milestones, deliverables, dependencies, risks, issues, decisions, budget-related updates, and corrective actions.
• Identify, manage, and escalate potential project roadblocks or hurdles that may impact project timeline, scope, quality, budget, stakeholder adoption, or intended business outcomes.
• Mentor Associate Project Managers and Project Managers in project planning, facilitation, documentation, risk management, stakeholder communication, and PMO practices.

Project Closing

• Verify all project objectives have been achieved, deliverables have been completed, final documentation has been organized, project performance has been evaluated, and business outcomes have been reviewed.
• Report on project success criteria results, metrics, and benefits realization, as applicable.
• Lead Lessons Learned reviews from the project and share findings with the Manager, Program Management Office to evaluate future process improvements.
• Organize and facilitate smooth and efficient forward progress of daily operations projects, as needed.
• Help department heads organize and run ongoing project meetings, as needed.
• Provide support needed by department heads to ensure ongoing smooth progress of assigned projects and programs.
• Assign action items and track status/completion to ensure continued forward progress of ongoing projects.
• Assist, as needed, with purchase order requests, vendor coordination, and budget-related project tracking.
• Serve as primary point of contact, as needed, for contract manufacturers, third party labs, consultants, and vendors associated with assigned projects or programs.

OTHER FUNCTIONS:

• Assist the PMO Office, as needed, with implementation of process initiatives and improvements to increase efficiency and productivity across the organization.
• Support PMO governance, portfolio reporting, project intake, prioritization, resource planning, and continuous improvement of project delivery practices.
• Continue professional development to keep abreast of emerging technologies, methods, and best practices.

Requirements

Qualifications

Education, Training & Certifications

Bachelor's degree in Science, Engineering, Business, Project Management, or another technical- or medical-related field, or equivalent applicable work experience. Advanced project management training or certification preferred.

Required industry experience:

10+ years of project and/or program management experience within medical device, pharmaceutical, biotechnology/biologics, diagnostics, or other FDA-regulated life sciences industries. Candidates should have with exposure to regulated processes such as Regulatory Compliance, GMP, Quality Systems, Design Controls, Product Development, Manufacturing, Validation, or Commercialization.

10+ years of experience leading complex, cross-functional projects, programs, or strategic initiatives. Proven ability to drive communication, coordination, stakeholder alignment, governance, accountability, and results. Experience managing project scope, schedules, budgets, risks, issues, dependencies, vendors, executive reporting, and organizational change impacts preferred. Experience mentoring project management professionals or providing direction to project teams preferred.

Skills & Capabilities

Advanced computer proficiency, including experience with Microsoft Project, Smartsheet, SharePoint, Microsoft Excel, and related collaboration tools. Demonstrated ability to lead complex projects and programs on time, within scope, and within approved budget parameters. Ability to lead, motivate, and manage project teams of varying sizes, including internal and external resources. Clear, confident, and executive-ready written and verbal communication skills. Strong organizational skills, attention to detail, and the ability to