Data Integrity Manager

WHAT ARE YOUR RESPONSIBILITIES?

  • You will manage the DI compliance on all GxP Computerized Systems – Instruments and Equipment 
  • You will lead Data Integrity Rollout strategy at the respective site
  • You will direct the efficient and effective execution of Data Integrity requirements across the site/campus
  • You will liaison with relevant cross-functional team ( DI Site program managers globally, mfg sites, R&D, IT, other) to coordination DI activities to leverage scale and maximize efficiencies accordingly. 
  • You will collaborate with other DI site program managers to share best practices and harmonized processes across the global mfg sites
  • You will Resolve timeline issues related to executional deliverables and develops tactical plans when necessary to bring back on track.
  • You will ensure Day to Day discipline to project plan and call out any risk of timeline gaps
  • You will ensure implementation of continuous improvement and process improvements programs
  • You will ensure adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.

WHO ARE WE LOOKING FOR?

  • You have an University degree in a technical discipline (e.g Engineering, Science, Information Technology)
  • You have more than 5 year’s  relevant experience with GMP processes, computer systems & data.
  • You have good Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices) 
  • You have good Knowledge of FDA validation and CFR 21 Part 11
  • You have good knowledge of various software applications and SAP ERP is a plus
  • You have the ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
  • You have experience in supply chain processes and systems 
  • You have knowledge of data integrity requirements
  • You are an excellent team player with strong analytical skills, negotiating and communication skills
  • You are communicative and writing strong in both Dutch and English

WHAT DOES QBD OFFER YOU?

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

  • Working for the Flemish Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ thanks to our extensive training package
  • A hip office with air hockey table
  • More muscle mass through our weekly boot camps
  • 32 vacation days that you wish were fewer (because it's great to work here ? )
  • A job with long term perspectives for further growth

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