Lab Systems Program Manager

SimoTech are seeking a Lab Systems Program Manager to oversee a global upgrade of lab systems projects for our pharma client. The project will include the implementation and enhancement of a variety of lab informatics systems such as LIMS, ELN, LES, SDMS and CDS.

Key Responsibilities
  • The program manager works to maintain the alignment of the program to the overall business strategy and to ensure the program is delivering the desired business benefits.
  • The program manager will communicate effectively to project teams, business stakeholders, and executive level management.
  • As challenges arise the program manager uses past project experience to develop and implement mitigation plans.
  • The Program manager will manage a global implementation team based in Ireland, Europe and India.
Requirements
  • Minimum of 5 years’ experience managing lab informatics projects in FDA regulated environments.
  • A science or technology degree.
  • Demonstrated ability to respond to project challenges.
  • Full life-cycle lab informatics project management experience from inception to implementation and go-live.
  • Ability to create and manage to, a project budget.
  • Demonstrated understanding and application of many of the following standards:
    cGxP, 21 CFR 11, CAP, CLIA, HIPAA, ISO 17025, 13485, ASTM, GAMP, PIC/S.
  • Business, scientific and/or technical understanding of at least one of following Labs systems:
    LabWare, SampleManager, STARLIMS, Empower, Nugenesis.
  • Computer systems validation experience is highly desirable.
  • Excellent verbal and written communication skills with the ability to communicate at all levels of the organization.
  • Business, scientific and/or technical understanding of Waters or BIOVIA product suites is a plus.
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.
  • Flexible working hours and location.

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