Insight Global is seeking an Operational Readiness Project Manager to support an exciting state of the art site expansion.
Must Haves:
Minimum of five (5) years of proven project management experience, to include: Leading change management projects & leading complex & major capital expenditure projects
Minimum of one (1) year of experience in pharmaceutical or biotechnology environment
Knowledgeable in GMP concepts
Knowledge of Lean principles & how they apply in a manufacturing environment
Ability to create & manage work plans & detailed project schedules required
Proficient in basic computer skills including experience with Microsoft Office
Pluses:
Master's Degree
Job Description/Responsibilities:
Leading multi-disciplined project teams to complete project tasks on-time, on-budget, meeting all requirements (quality, cost, schedule, scope).
Developing and executing assigned project plans in accordance with the scope, schedule, quality, impact, and cost objectives.
Negotiating required staffing with LOB and assisting with required training of personnel supporting the project.
Managing, coordinating, and directing contract resources and internal resources.
Refining and clarifying project scope through early project analysis with subject matter experts and owners to further substantiate project purpose.
Providing clear goals to ensure effective use of time and resources and build employee motivation.
Monitoring and controlling project work with stringent follow-up on quality, schedule, and budget to ensure the project delivers the desired end-product.
Monitoring and reporting project progress, communications to management and other stakeholders, and presentation in steering groups.
Supporting building, managing, and improving Project Portfolio Management systems, ensuring alignment with global programs and other site projects to share best practice, knowledge, and visions, as well as ensuring all facets of the program lifecycle align with expectations set forth by the project owner.
Supporting project team members mentoring and onboarding, following all safety and environmental requirements in the performance of duties, and fulfilling other accountabilities as assigned.
Assist in building the GMBR template for all FFEx filling, collaborating with global filling SMEs, MES Analysts, and PAS-X SMEs.
Attend GMBR status update meetings, drive global action items, and participate in specialized topic discussions related to GMBR.
Develop and manage the local IT/OT GMBR implementation schedule for filling, ensuring coordination with the overall local implementation schedule and securing necessary resources.
Actively monitor and manage the implementation plan, ensuring adherence to schedule and effective communication with key stakeholders.
Coordinate and drive actions with external vendors and program resources, particularly in reviewing the open action item list for the GMBR template finalization.
Oversee and manage local MDR tasks, ensuring alignment with global requirements and facilitating information sharing across FFEx sites.