Project Manager -GxP Validation

Company: Nexient LLC
Location: Washington
Posted on: November 8, 2024

Job Description:

Req ID:299676NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a Senior Project Manager -GxP Validation to join our team in Kalamazoo, Michigan (US-MI), United States (US).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. 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 projects 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.INDHCLSMCAbout NTT DATANTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at .NTT DATA is an equal opportunity employer and considers all applicants without regard to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
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Keywords: Nexient LLC, Silver Spring , Project Manager -GxP Validation, Executive , Washington, Maryland