IT Sr. Project Manager –GxP Validation; East Coast, US​/Remote

IT Sr. Project Manager –GxP Validation (East Coast, US/Remote)

Our Project Management practice group is currently seeking a Sr IT Project Manager who has strong experience with cloud based solutions to support one of our global Healthcare devices/Life Science clients, based out of Kalamazoo, MI. In this role, the Sr IT Project Manager will be responsible for the Regulatory and compliance aspects of a cloud based implementation. A successful candidate would leverage effective project management practices, working collaboratively with various divisions and cross functional teams globally while delivering cost-effective implementation exceeding stakeholder expectations.

• Independently Lead the detailed planning and management of the project from inception to project completion
• Ability to understand Validation, Transparency Laws, Integration of Healthcare/Pharma systems/Legacy systems
• Experience with working in validated systems and nuances of computer system validation
• Experience managing large project involving multiple IT teams and systems
• GxP validation process
• Stakeholder communication and presentation experience
• Manage scope, budget, and schedule for project success.
• Create, maintain, and share all project related documents like charter, plan, risk register, issue list, presentations etc.
• Establish and maintain the project information in PPM tool
• Meet budgetary objectives and adjust project constraints based on financial analysis
• Develop comprehensive project plans to be shared with clients as well as other staff members
• Use and continually develop leadership skills
• Establish cadence and project status communications with stakeholders
• Manage the Change Control process for assigned projects
• Ensure project milestones and targets are met by actively managing project on a day to day basis through appropriate resource, issue, and risk management
• Successfully deliver assigned projects to targets (on time, on budget, and in scope)
• Lead cross-functional team meetings and ensure capture of discussion points and action items
• Lead and participate in testing of system requirements, as needed
• Work with business managers to propose and justify new technology-based business improvements

• Minimum 15 years of experience as IT project manager
• 5+ years work experience in Pharma/healthcare (e.g. Biotech, Pharma, Medical Equipment, etc.)
• Bachelor's Degree in computer science or relevant field
• 5+ years of cloud based solution implementations
• Certified in PMP/Agile/Scrum framework

• Experience implementing Healthcare/Pharma system cloud Integrations
• Cloud based solutions
• Strong project management skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
• Life Science Pharma – GxP, Transparency Laws, Validation process
• Demonstrates self-discipline and motivation in all aspects of job performance
• Strong organizational Skills
• Project Management experience – with vendor management/ risk/ Issue/Performance Management
• Strong Soft Skills
• Strong verbal, written and presentation skills.
• Understanding of business processes related to pharmaceutical regulations
• Able to complete assignment with minimal direction
• Self starter, Independent mindset to drive from initiation to completion work with Sr Leadership/global stakeholders
• Must be able to work in a high-pressure team environment, handle multiple tasks and react quickly to networking problems and issues
• Familiarity with Planview is a plus
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
• Strong client support orientation
• Agile/Scrum project experience