Project Manager

What are your responsibilities?

  • Represent and manage the delivery of site and NPI (New Product Introduction) projects. The delivery of these projects will require GMP utility, facility and supporting system changes. 
  • They must investigate and deploy innovative solutions to improve the efficiency of our current installations.
  • Ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements. 
  • They will work directly with SMEs, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met. 
  • Generation of proposals for the 2019 program. 
  • Execute projects to Amgen Project Execution Plan (PEP) and meet all GMP requirements. 
  • Ensure the highest levels of project safety. 
  • Perform continual project risk analysis. 
  • Identify project critical paths and prioritize accordingly. 
  • Discover and understand end-user/process requirements; translate these into user requirements specifications. 
  • Manage the compilation of all project documentation. 
  • Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs. 
  • Manage day to day project activities including permitting/method statement review etc. 
  • Develop and document strong rational for testing strategy, acceptance criteria, and results. 
  • Generate, review, and/or approve protocols, reports ensuring robust documentation for regulatory adherence. 
  • Monitor installation quality and record inspections – Comply to Amgen and Dutch standards. 
  • Set up and manage communication channels – Weekly report out/Project Team Meetings. 
  • Follows a strict handover process to allow for future system maintenance. 
  • Managing Key business stakeholders expectations/interactions (Planning, Manufacturing, Warehouse & Distribution, Customer Service and Quality). 
  • Work with impacted functions to ensure alignment and operational readiness of new installations. 
  • Manage resource & skills allocation and management of day-to-day activities. 

Who are we looking for?

  • MSc/HBO in a Life Sciences related field such as Life Science and technology, Biomedical Engineering & Biotechnology
  • Experience in a pharmaceutical/GMP environment 
  • Experience in a labeling and packaging environment 
  • Project management qualification or 5+ years Project Management experience 
  • Experience with MS Project 
  • Cost/budget control Experience
  • Prior Experiences with Change management 
  • Excellent communication skills

What does QbD offer you?

  • A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package

Interested? Apply now by sending us your CV and motivation.