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Let's push the boundaries together and make the most of your talents!

Quality Partner BeNeLux

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Quality Assurance
Job ID:  65472

Quality Partner BeNeLux

 

Help us transform patients’ lives

 

At UCB, we put heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Regional Quality team, based in our Headquarters in Anderlecht, Belgium, we are looking to fill the position of Quality Partner for BeNeLux, part of UCB Northern European area affiliates.

Are you known for your logical ways that are supported by your collaborative nature? You are a ‘logiborative’ person at UCB. This remarkable blend of talent means you are adept at thriving on reason for the cause of patient comfort.     

 

As a UCB ‘logiborative’ person and Quality Partner you like to work in an environment where you can:

  • Contribute to the implementation of UCB global quality practices and promote compliance with relevant cGDP (and cGMP, where scope is limited to importation from 3rd countries) and local regulations in the UCB affiliates of Belgium and the Netherlands. 
  • Ensure all Regional Quality deliverables are achieved in a timely manner.
  • Be the single point of contact for all quality related matters in the area including Health Authority communications.
  • Be part of a small international Northern European Quality team where you can develop with support and advice from collegues in similar positions.

 

As a UCB ‘logiborative’ person and Quality Partner you will contribute by:

  • Implementing and maintaining an effective and compliant Quality System in line with the Regional Quality strategy and according to UCB policies and procedures, cGxP and applicable local regulatory requirements
  • Maintaining relevant Affiliate authorizations and certificates
  • Executing and coordinating operational quality activities for the area (potential for becoming Responsible Person GDP in the Netherlands and QP in the Netherlands and Belgium and Narcotics responsible tasks in both countries)
  • Executing and overseeing the local quality operations (e.g. audits, complaints, deviations, CAPAs) including quality governance and quality planning in the countries
  • Maintaining the Quality Manual and applying a Quality Risk Management approach
  • Ensuring that contact on quality matters is maintained with the local Regulatory Authorities, the local vendors (wholesalers, service providers) as well as UCB Northern European area and Corporate Quality
  • Contributing to and/or hosting self-inspections, internal corporate audits, and Regulatory Authority inspections.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Ideally min. 3 years working in the pharmaceutical industry, in operational quality management (GDP) or Qualified Person position (our GMP scope is limited to importation from 3rd countries). Experience in affiliate quality position would be preferable.
  • Experience interacting with regulatory bodies and third-party organizations with respect to Quality systems and regulatory inspection preparedness.
  • Strong knowledge of European and Belgian legal requirements of the pharmaceutical industry, including the interpretation and practical application of regulations. Good background knowledge of the pharmaceutical industry from a business and technical perspective.
  • Ability to act without direct supervision and handle complex/difficult situations.
  • Good quality auditing mindset, root cause and risk management/assessment skills.
  • Ability to effectively interact and communicate in Dutch, French and English (verbally and written) with internal and external stakeholders on projects, product and quality related matters.
  • Experience and/or willingness in operating across cultures and in a multi-cultural environment.
  • Eager to learn and develop yourself.

 


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