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

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kasmo globalDenver (CO)

Project Management Specialists Computer Systems Design Services

SENIORITY

Manager

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About the role

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.

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 SkillsStrong 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

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