Project Manager - Quality & Change Management

Project Manager - Quality & Change Management

Duration: 12 Months (Possible Extension)

Location: Hybrid - Sheridan Road, North Chicago, IL 60064 (3-4 days remote per week)

Overview

We are seeking a Project Manager (Non-IT) to support Quality and Change Management activities related to product lifecycle processes. This role focuses on executing and managing Change Plans for operational or product-related changes, ensuring that all required tasks, documentation, assessments, and approvals are completed according to quality guidelines.

The position operates in a cross-functional matrix environment and will collaborate closely with teams across Supply Chain, Regulatory, and Quality to ensure product lifecycle changes are implemented smoothly and in compliance with regulatory and quality standards.

Key Responsibilities:

Change Plan Management

• Serve as the Change Owner responsible for setting up and managing Change Plans related to product lifecycle activities.
• Drive the initiation, execution, and completion of change plans for operational or product-related changes such as packaging updates, process modifications, distribution changes, or documentation updates.
• Identify impacted products, markets, and stakeholders and ensure all required actions are documented and completed.
• Track and manage tasks, approvals, and timelines until the change plan is successfully closed.

• Work closely with Supply Chain, Regulatory, and Quality teams to gather required information and complete change plan activities.
• Organize and lead project planning meetings with cross-functional teams.
• Coordinate with stakeholders to identify task owners, approvers, and due dates for required actions.
• Follow up with stakeholders to ensure tasks and documentation are completed on time.

• Create and maintain change documentation within Quality Management Systems (QMS).
• Work with change control tools and workflow systems such as: OneTrack, TrackWise, SolTRAQs
• Ensure change records follow established quality guidelines and documentation standards.

• Monitor progress of change plans and track action items and approvals.
• Compile and maintain metrics and reports, including: Open change plans, Outstanding tasks, KPI tracking
• Support reporting activities using Excel and internal reporting tools.

• Identify opportunities for process improvements, automation, and workflow optimization.
• Maintain a backlog of improvement opportunities and prioritize initiatives.
• Support implementation of initiatives to improve operational efficiency.

• Bachelor's degree with 4-8 years of equivalent professional experience
• Experience in Project Management and Change Management
• Experience working in cross-functional or matrix environments
• Strong organizational and communication skills
• Ability to manage multiple tasks and coordinate with stakeholders
• Experience working in regulated industries (pharmaceutical, healthcare, food, or similar)
• Ability to work independently and manage projects through completion

• Experience working in pharmaceutical, life sciences, or healthcare industries
• Familiarity with Quality Management Systems (QMS) or change control platforms
• Experience with workflow tools such as OneTrack, TrackWise, or SolTRAQs
• Understanding of product lifecycle processes and validation documentation
• Experience working with data tracking, KPI reporting, or operational metrics

• Project Management, Change Management / Change Control, Cross-Functional Team Leadership, Quality Systems Documentation, Stakeholder Coordination, Process Improvement, KPI Reporting & Data Tracking, Excel Reporting.

• Set up and manage Change Plans related to product lifecycle activities.
• Coordinate meetings with cross-functional teams to define scope, tasks, and timelines.
• Collect and track information required for change documentation.
• Assign and follow up with task owners and approvers.
• Ensure documentation and system updates are completed within defined timelines.
• Monitor change plan status and escalate risks or delays when necessary.
• Track metrics and compile reports related to change activities.