Sr. IT Project Manager GxP Validation

Title: Sr. IT Project Manager GxP Validation

Location: Kalamazoo, MI (Remote)

Type: Contract

Job Summary:

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.

Responsibilities and Duties:

• 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

Basic Qualifications

• 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

Preferred Experience and Skills:

• 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

VDart Group, a global leader in technology, product, and talent management, empowers businesses with comprehensive solutions through our four distinct, industry-leading business units. With a diverse team of over 4,000 professionals across 13 countries, we deliver strong results across various industries, including Fortune 500 companies.

Leveraging our deep expertise as a global provider of resources and solutions, we serve a wide range of industry verticals, including BFSI, Automotive, Healthcare, Mobility, Energy, Life Sciences, Manufacturing, Consumer Industries, and Technology.

With over 16 years of experience, VDart has evolved to meet the needs of leading technology brands, placing and training more than 20,000 professionals and shaping the industry's future.

Our continuous reinvention, providing resources for IT solutions and unique digital solutions, has positioned us as a top growth leader in digital talent management and technology consulting.

Committed to "People, Purpose, Planet," we prioritize social responsibility and sustainability, as evidenced by our EcoVadis Bronze Medal Certification and participation in the UN Global Compact.

Our dedication to delivering strong results has earned us recognition as a trusted advisor for businesses seeking to drive innovation and growth, including many Fortune 500 companies.

Join our network! Partner with VDart Group to leverage our global network, industry expertise, and proven track record with a diverse clientele.