IT Project Manager - Trackwise Implementation

Planet Pharma is seeking a seasoned Senior IT Project Manager to lead the enterprise implementation of TrackWise Digital across three U.S. manufacturing sites. This role involves overseeing the full lifecycle of the implementation program, collaborating with various teams to ensure project success, and maintaining compliance with regulatory standards.

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
• Regulatory Compliance & Validation Expertise
• 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