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CQV Project Manager

  1. United States
Maryland
  1. Contract
Competitive
  1. CAPEX Projects
09-04-2024
33515
CQV Project Manager - Maryland, United States - 12-Month Contract 

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a CQV Project Manager to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!


Responsibilities:
  • Head up the active role in the implementation of recurrent coordination meetings, workshops and training during the project.
  • Structure and consolidate key challenges in the project during the various phases for communication and escalation.
  • Present project key issues/decision with strong story line and clear messaging during all phases. The target groups are the project management, the project governance, the program management.
  • General facilitation of project and design decision processes through the phases.
  • Plan, prepare, facilitate, and document workshops and other key project activities as appropriate.
  • Run overall discussions and alignments when these occur, with the responsibility to solve any technical and management issues rising within Project Management.
  • Take up the leading CQV role across the program.
  • CQV PM responsible for the CQV Team and Deliverables from Concept Design through to successful PPQ Runs.
  • Have valued into each Design Stage for Project, Concept, BOD and Detailed Design, ensuring at all times that all Quality and Compliance deliverables are included in Design.
  • Build CQV Team from Day 1 on Project to ensure the Team is in place to deliver the project at each stage – Design, Document Generation, FAT, Mechanical Completion, Set to Work, PreSafety Start up Reviews, Commissioning, Qualification and full handover to Operations.

Experience:
  • BS Engineering (or equivalent experience)
  • 15+ years working CQV experience in the Pharmaceutical Industry (preferable in Biologics manufacturing)
  • Exceptional teamwork abilities
  • Strong knowledge of GMP’s, regulatory requirements
  • Excellent written and verbal communication skills for both technical and non-technical audiences

If this role is of interest to you, please apply now! 

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