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

Development QA Systems, GSP Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  64970

Development QA Systems, GSP Lead

 

Help us transform patients’ lives.

 

At UCB, we put our 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 Development QA Systems, based in our hub in Braine L’Alleud, Belgium, we are looking to fill the position of: Development QA Systems, GSP specialist.

 

Do you often approach matters in an innovative and collaborative way? At UCB, we see you as an ‘innoborative’ person. This extraordinary blend of talent means you are often thinking in new ways with others for the sake of patients.

 

As a UCB 'innoborative' person and Development QA Systems, GSP specialist you like to work in an environment where you can:

  • Apply your team worker, facilitator and influencer skills, in a challenging and motivating environment (development entities)
  • Participate in cross-functional meetings and projects
  • Use your scientific, continuous improvement, and problem-solving skills
  • Be a key actor in the deployment of a fit-for-purpose, science based, new quality system for development entities (not operating under GMP regulations)

 

As a UCB 'innoborative' person and Development QA Systems, GSP specialist you will contribute by:

  • Acting as an internal consultant for development entities (BioTech Sciences and Pharma Sciences) performing GSP – Good Scientific Practice (non-GMP) activities, ensuring the establishment, implementation, maintenance, and continuous improvement of a Quality Management System (QMS) linked to product development from pre-clinical to phase IV activities.  
  • Providing guidance, and expert advice to development scientists, particularly with regard to the appropriate interpretation of internal Policies. You will identify, mitigate and subsequently resolve compliance and quality issues that may affect UCB development activities and products
  • Implementing and maintaining a quality risk management process for the systems used in Development
  • Providing routine support for development entities (qualification and validation activities, training, building and maintaining compliance indicators, problem solving, audit preparation,…)

 

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

  • Master degree - scientific background
  • 10 years' experience in pharmaceutical industry with a minimum of 5 years’ experience development entities (in a pharmaceutical regulated environment (business or quality)
  • A comprehensive knowledge of current regulatory requirements and ability to interpret current regulations is required
  • Specific expertise in data integrity regulations is an asset
  • Function effectively with minimal supervision
  • Good teamwork and project management skills. Must have strong, organization and analytical skills.
  • Must be fluent in English, other languages are a bonus
  • Facilitator, influencer and planer
  • Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on "grey" issues
  • Familiarity with problem solving and risk analysis techniques
  • Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities and provide prioritization

 


Job Segment: Biotech, Law, Quality Manager, Product Development, Pharmaceutical, Science, Legal, Quality, Research

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