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IT GxP Applications Project Manager (Pharma)

Newark, CA · Biotech/Pharmaceutical
Title: IT GxP Applications Project Manager (Pharma)
Type of role: Contract / hybrid (local candidates preferred)
Location: Newark, CA

*Must have previous Pharma or Biotech and GxP exp.*

Our growing Biotech client is looking for an IT Applications Project Manager with previous Biotech experience to lead GxP IT Projects.

Job Details
  • Responsible for project planning, scheduling, monitoring, and reporting for various sized projects (both GxP and Non-GxP)
  • Facilitates the definition of project milestones, goals, tasks, and resource requirements and development of recommended alternatives
  • Resolves or assists in the resolution of conflicts within and between projects or functional areas.
  • Responsible for assembling and on-boarding the project staff. Ensuring responsibilities of resources are communicated and understood.
  • Ensures that all projects are delivered on-time, within scope and within budget.
  • Measures project performance using appropriate systems, tools, and techniques.
  • Develops project scope and objectives, involving all relevant stakeholders.
  • Supervises risks, issues, assumptions, dependencies, changes in project scope, schedule, and costs.
  • Reports and escalates to the PMO as needed and manages status update meetings with project team members.
  • Creates and maintains project documentation, including preparation for stage gate reviews.
  • Minimum of 7 years’ experience in IT Project Management
  • Bachelor’s degree required, Master’s degree a plus, preferably in the fields of Business, Biology, Computer Science, Information Management or Engineering.
  • Experience managing projects across a wide range of technologies including software and business process and completed major cross functional projects.
  • Understanding of different Project Management principles and methodologies, proficiency with PM tools with at least one Enterprise PM software tool (Smartsheet, SharePoint, Microsoft Project, etc.)
  • Experience in Pharma/Biotech environment.
  • Technical background, with understanding or hands-on experience of software development. Understanding of end-to-end IT delivery and operations.
  • PMP certification and System validation GxP experience preferred
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