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Project Manager
Ref No.: 18-00040
Location: Baltimore, Maryland
Start Date: 10/22/2018
Project Manager

Description:

We have an exciting contract opportunity for an experienced IT Project manager looking to develop their skills with a fast-growing Biotech company. The role will report to the IT Program Manager in support of our ERP and QMS platform initiatives.

Duties & responsibilities:
  • Establish and maintain the Project WBS (Work Breakdown Structure) & Budget during the Project Concept Phase and maintain during the life of the projects.
  • Established, manage and communicate the means identify, document, escalate, and track Outstanding Project Issues.
  • Support the Program and Projects' Communications Plans
  • Establish and support the methods to identify, document, scope, approve, and track Change Requests.
  • Support the development of the Stage Review Presentations in partnership with the Program Manager.
Skills & technical expertise:
  • Proven record of strong project management and/or program management proficiency, with an emphasis on GMP systems installation and validation, IT System Development Life Cycle, and Change Control methodologies and processes.
  • Experience in deploying GMP Cloud based systems preferred.
  • Excellent knowledge of application architectures and business process improvement techniques.
  • Demonstrated success in building strong relationships across client organizations and vendors.
  • Demonstrated ability to analyze and define project problems early and identify appropriate means to address with the team
  • Ability to closely manage to a dynamic budget is essential.

Required:
  • Proven record of successful realization of ERP or QMS solutions.
  • Excellent understanding of cGMP's and System Development Life Cycle methodologies.
  • Excellent facilitation, problem solving, and communications skills.
  • Working knowledge of the regulatory requirements for pharmaceutical applications
  • Understanding of ITIL support methodologies.
  • Experience in supporting QMS and/or ERP platforms in a GXP environment.
  • Demonstrated understanding of quality and compliance
Desired:
  • Proven facilitation, meeting/workshop management, project management and change management skills.