QA Regulatory Intelligence Lead

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Date: Feb 17, 2019

Location: Braine L'alleud, Walloon Brabant, BE

QA Regulatory Intelligence Lead

 

Location: Braine l’Alleud, Belgium

 

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 Global Quality Assurance department, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of:

 

QA Regulatory Intelligence Lead

 

Do you describe yourself as helpful? Are you a futurist? Add these two together and you're a ‘helpfulurist’ at UCB. This unique blend of talent means you are a cooperative forward thinker with patient wellbeing in mind.

As a UCB 'helpfulurist' and QA Regulatory Intelligence Lead Network (RIN/veille reglementaire) you like to work in an environment where you can:

 

  • Apply your organizational skills: Manage the monitoring, triage and assessment of regulation changes specific to biopharmaceutical manufacturing (GMP/GDP), while ensuring the coordination of  and interaction with our other regulatory intelligence leads in the GXP RIN (veille reglementaire) program.
  • Think strategically: Be responsible for global RIN program strategy, process improvements and ensuring monitoring output from all UCB strategic markets; developing and executing a RIN communication plan for key stakeholders as well as the broader GMP/GDP audience; participate in advocacy strategy efforts
  • Work your network: Be in contact with a wide audience of stakeholders and experts internally and externally to have the latest regulation developments

 

As a UCB 'helpfulurist' and QA Regulatory Intelligence Lead (RIN/veille reglementaire) you will contribute by:

 

  • taking responsibility as regulatory intelligence leader collaborating with UCB regulatory intelligence leaders
  • Managing the monitoring of all applicable GMP/GDP/Device/CMC regulations in a organized fashion according to UCBs global strategy
  • Developing and executing monitoring tools and maintaining a stable flow of signals and ensuring the monitoring output is assessed for impact to UCB, collaborating with relevant experts
  • Driving new and changed regulation implementation using a risk-based approach with relevant process owners and SMEs, tracking the execution by the business
  • Creating content for and publishing the RIN Newsletter
  • Developing an inspection intelligence monitoring and reporting process
  • Developing a RIN communication plan for key stakeholders as well as the broader UCB audience
  • Participating in advocacy efforts for UCB based upon a strategic plan; participate or connect with advocacy networks
  • Acting as internal consultant for key regulatory topics

 

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

  • Minimum 8 years working in the life science industry
  • Minimum 5 years working in quality assurance
  • Experience with global GMP regulation
  • Preferred experience with ICH Q10 Quality Systems or equivalent (ISO)
  • Strong organizational and project management skills
  • Fluent in English and strong interpersonal skills
  • Strong technical writing and communication skills
  • Be able to work with minimal direction, with a high degree of independence

 

To apply please go to www.ucb.com/careers.

 

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.

 

 

 


Job Segment: Regulatory Affairs, Law, QA, Quality Assurance, Legal, Quality, Technology

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