Strategic Project Manager – Regulated Manufacturing

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Harba Solutions Inc. is seeking a Project Manager to lead multiple cross-functional initiatives in a highly regulated manufacturing environment. You will coordinate schedules, milestones, and resource plans while ensuring scope and timelines are met.

You will collaborate with Operations, Quality, Engineering, Regulatory, and Supply Chain teams to drive execution, manage risks, and communicate progress to senior leadership, supporting continuous improvement and governance practices.

Qualifications

• 1+ years of project management experience in regulated manufacturing.
• Experience coordinating cross-functional projects across operations, engineering, quality, and supply chain.
• Proficient in Microsoft Excel and Microsoft Project.
• Familiar with GMP and quality systems.
• Experience with process improvements or product launches.
• Strong written and verbal communication with stakeholders.
• Knowledge of PMO, governance, or portfolio management.
• PMP or Lean/Six Sigma is a plus.
• Bachelor's degree in Engineering/Life Sciences/Business or related field preferred.

Responsibilities

• Lead cross-functional initiatives supporting manufacturing operations and product lifecycle.
• Develop and maintain project schedules, milestones, and resource plans.
• Collaborate across Operations, Quality, Engineering, Supply Chain, and Regulatory.
• Facilitate meetings and provide leadership with risk and timeline updates.
• Support planning with scope development, cost estimates, and implementation strategies.
• Coordinate activities among technical, manufacturing, validation, and quality teams.
• Improve project management processes and portfolio visibility.
• Monitor risks and develop mitigation plans to ensure delivery.
• Utilize project management software to track progress and communicate status.
• Assist with strategic operational initiatives and business integration.

Skills

Project management

Cross-functional coordination

Multitasking

Stakeholder communication

PMO governance

GMP compliance

Process optimization

Leadership across levels

PMP/Lean Six Sigma

Bachelor's degree

Education

Bachelor's degree (Engineering/Life Sciences/Business)

Tools

Microsoft Excel

Microsoft Project

Job description

Harba Solutions Inc. is seeking a Project Manager to lead multiple cross-functional initiatives in a highly regulated manufacturing environment. You will coordinate schedules, milestones, and resource plans while ensuring scope and timelines are met.

You will collaborate with Operations, Quality, Engineering, Regulatory, and Supply Chain teams to drive execution, manage risks, and communicate progress to senior leadership, supporting continuous improvement and governance practices.