Summary

Develops and implements PMO processes and policies, collaborates with company stakeholders to define, prioritize and develop project resources, project teams and tracks them. Manages the product lifecycle for an in vitro molecular diagnostic test and works closely with assay reagent scientists and hardware developers.

Essential Duties (Identify which are QMS responsibilities)

  • Lead planning and execution of multiple high-visibility projects supporting operations and capacity expansion initiatives
  • Lead cross-functional and technical teams to execute on project priorities and timelines.
  • Produce and monitor overall project schedules, issues, risks, and opportunities
  • Interface with external vendors, as required, to ensure appropriate engagement and accountability in conjunction with internal resources and activities.
  • Prepare, maintain, and present monthly program updates, action plans, and status reports for leadership reviews.
  • Establish and maintain the Product Life Cycle (PLC) delivery process to ensure quality and efficiency in program execution.
  • Continuously evaluate and refine tools and processes to ensure they are efficient, high quality, and scalable.
  • Operate as a change champion and actively gather metrics and feedback on to measure program effectiveness.
  • Work closely with Product Managers, R&D and Manufacturing teams for NPI/Product Transfer, Assay Development, Mechanical Engineering, Systems Engineering to drive successful project implementation. 
  • Participate in the selection, training and performance appraisal process of project resources, including temporary contract SMEs as required.
  • Establishment of priorities, imparting a sense of urgency and importance to the team while using project management tools and techniques to support the delivery of new products per cost and time commitment.
  • Other duties as assigned.

Education and/or Experience

  • Bachelor of Science in Life Sciences or Engineering discipline required; Master of Science preferred.
  • PMP certification is preferred.
  • 5+ years of Project Management experience required. 
  • Proficiency with JIRA, Smartsheet/ MS Project required.
  • Experience in Biotech, Pharmaceutical, Clinical Trial, Life Science, or Medical Device (ideally Clinical Trial/FDA/PMA/510k submission) industry is a plus.
  • Product Development experience (understands instrumentation/reagents/firmware) preferred.
  • Experience in Quality System Regulations (QSR) 21 CFR 820 and Design Control: ISO 13485:2016) is a plus.

Other Qualifications

  • Strong program management experience (leadership, project tracking, schedules, timelines, budgets, communication).
  • Strong written and verbal communication skills.
  • Proven negotiation, issue resolution and team building skills.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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