Information Technology Project Manager

Fusion Life Sciences Technologies LLC is seeking a seasoned Senior IT Project Manager to lead the implementation of TrackWise Digital across three U.S. manufacturing sites. This role involves driving cross-functional execution in a regulated environment while ensuring alignment with global project designs.

Responsibilities:

• Lead the full lifecycle of the TrackWise Digital implementation program—from business case development through go live and post launch stabilization
• Oversee system testing, including test planning, execution, issue tracking, and documentation
• Collaborate with the U.S. Deployment Lead, business SMEs, and IT teams to define deliverables and manage project tasks
• Develop and manage integrated project plans, governance frameworks, resource strategies
• Work with Business PM to manage project scope, timeline, RAID logs, and prepare executive level updates for steering committees

Requirements:

• Strong project and people leadership skills, with the ability to guide cross functional teams across Quality, Regulatory, Manufacturing, IT, and Operations
• Demonstrated ability to maintain open, proactive, and consistent communication with project leads, SMEs, technical teams, and stakeholders at all levels
• Excellent written and verbal communication skills, with the ability to articulate complex technical and business concepts
• Experience managing multiple concurrent projects in a fast paced, highly regulated environment
• Proven ability to maintain accurate, detailed documentation within a GxP regulated pharmaceutical or life sciences setting
• Solid understanding of key regulatory and validation frameworks in a pharma environment, including but not limited to: FDA 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+)
• Hands on experience managing the full computerized system validation (CSV) lifecycle, including: URS and Functional Specifications, Risk Assessments, IQ/OQ/PQ Execution, Traceability Matrices, SOP updates and release documentation
• Ability to apply modern Computer Software Assurance (CSA) approaches for cloud based/SaaS systems
• Minimum 5 years of IT project management experience within pharma, biotech, or life sciences
• Strong proficiency with Microsoft Office and collaborative project management tools
• Experience with TrackWise Digital or other eQMS platforms
• PMP, Scrum master Certified