• Sr. Operational Readiness Project Manager

    Insight Global (Holly Springs, NC)


    Job Description

    Day to Day:

    A large pharmaceutical client is looking for 2 Sr. Operational Readiness Project Managers to join their team in Raleigh-Durham. In this role you will be responsible for overseeing a successful turn over of both upstream and downstream equipment to ensure manufacturing is ready for operations. This role will be based onsite 5x per week.

    • Lead project scope definition for Operational Readiness workstreams such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control, among others

    • Develop execution strategies, detailed schedules, and risk registers

    • Integrate and actively facilitate workstreams day-to-day execution

    • Facilitate teams meetings and execution forums

    • Represent workstreams in appropriate governance forums

    • Liaise with other project PMs to ensure effective project delivery

    • Closely manage schedule performance and provide updates to management

    • Ensure internal alignment of operational readiness schedules, as well as externally with construction and commissioning/qualification workstreams

    • Provide strategic guidance on overall project delivery to de-risk and optimize execution

    • Resolve workstream issues arising throughout the project, manage risk register, and escalate when appropriate to keep objectives and deliverables on track

    • Lead and facilitate cross-functional workshops required to ensure project alignment, solve project challenges, identify gaps, and advance site strategy

    • Won't manage people, nor budget

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and Requirements

    Must Haves:

    • 10+ years of Project Management experience

    • Experience in Biologics Drug Substance manufacturing operations (ideally Downstream and/or Upstream operations)

    • Understanding of the change control process

    • Understanding of manufacturing support systems (ie MES, PI, DeltaV, etc)

    • Understanding of operations support systems (ie Trackwise, LIMS, Maximo, etc)

    • Understanding of supporting functions within a biopharmacautical operation (ie Quality Control, Process Development, Engineering, etc)