Senior Specialist, Change Management

Lake County, IL, US
Oct 09, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Change Specialist is responsible for leading and supporting Operations change management processes ( project management) to ensure successful change control implementation for drugs, biologics, and medical devices. This position collaborates with stakeholders across businesses, functions, and sites in order to develop robust change strategies and maintain them in the Change Management IT system. Other functions of the role include (but are not limited )

Key Responsibilities Include:

  • Manages key processes in the development and execution of Global and/or local change plans related to new product introduction, growing products, product discontinuations, and other business-driven initiatives that span multiple franchises
  • Plans and leads Change Review Board meetings and other cross-functional team meetings to facilitate the review and approval of change plans
  • Collaborates with requestors of change through the development of new change plans and with plan owners to drive progress of open plan/task completion
  • Drives accountability and is responsible for the compliance of change plan documentation, in accordance with established procedural requirements
  • Leverages data/metrics to identify opportunities for continuous improvement; provides recommended solutions to the Change Review Board that drive efficiency/effectiveness of the change management process or enhance business prioritization
  • Develops communications around process improvements and lessons learned to support the governance of the change management process
  • Serves as a member of the Change Management Community of Practice and Center of Excellence


  • Bachelor's degree plus 5 years of relevant professional experience OR high school degree plus 10 years of relevant professional experience required
  • 5 years of Medical Device or Pharma industry experience required
  • 3 years of Change Management experience required
  • In-depth knowledge of FDA regulations, ISO standards, and ICH guidelines required
  • TrackWise and SolTRAQs experience required
  • Technical writing experience required

Equal Opportunity Employer Minorities/Women/Veterans/Disabled