About The Position

Your responsibilities will include: Manage all phases of the project lifecycle, including initiating, planning, executing, controlling, and closing processes. Develop and implement comprehensive project plans and foster team ownership and accountability for deliverables. Prepare detailed schedules, budgets, and timelines using project management tools such as Microsoft Project. Coordinate cross-functional alignment with Quality, Regulatory, Data Science, IT, Legal, and global site teams to ensure smooth delivery and adoption of AI solutions.

Requirements

  • Bachelor's degree from an accredited institution.
  • Minimum of 5 years' experience coordinating and/or leading software validation projects or IT/technology-related projects in a regulated environment.
  • Professional experience in the pharmaceutical and/or medical device industry.
  • Demonstrated knowledge of change management methodologies and their application in project environments.
  • Proven experience collaborating with multiple internal stakeholder groups, including site, division, and regional Quality and Regulatory teams.
  • Ability to work effectively with individuals at all organizational levels and with external vendors or consultants.
  • Ability to meet project deliverables and performance expectations in fast-paced or evolving environments.
  • Ability to work independently and assume responsibility for assigned project outcomes.
  • BS degree in Engineering or IT.
  • PMP Certification.
  • Understanding of software validation/CSV principles.

Responsibilities

  • Manage all phases of the project lifecycle, including initiating, planning, executing, controlling, and closing processes.
  • Develop and implement comprehensive project plans and foster team ownership and accountability for deliverables.
  • Prepare detailed schedules, budgets, and timelines using project management tools such as Microsoft Project.
  • Coordinate cross-functional alignment with Quality, Regulatory, Data Science, IT, Legal, and global site teams to ensure smooth delivery and adoption of AI solutions.
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