Insight Global
Sr. Project Manager - Operational Readiness
Insight Global, Holly Springs, North Carolina, United States, 27540
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 HR@insightglobal.com.To 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)
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 HR@insightglobal.com.To 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)