Lead GMP Corporate QA Regulatory Intel
Date: Dec 3, 2018
Location: Braine L'alleud, Walloon Brabant, BE
Lead, GMP Corporate QA Regulatory Intelligence Network (RIN)
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: Lead, GMP Corporate QA Regulatory Intelligence Network (RIN).
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 Lead, GMP Corporate QA Regulatory Intelligence Network (RIN) you like to work in an environment where you can:
* Manage the monitoring, triage and assessment of regulation changes specific to GMP/GDP, while ensuring the coordination of the GXP RIN program.
* Be responsible for global RIN program 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
* Be in contact with a wide audience of stakeholders and experts internally and externally
As a UCB 'helpfulurist' and Lead, GMP Corporate QA Regulatory Intelligence Network (RIN) you will contribute by:
* Acting as the GMP/GDP RIN leader collaborating with GXP RIN leaders
* Managing the monitoring of all applicable GMP/GDP/Device/CMC regulations using a classification according to QMS topics and internal strategy
* Developing and executing monitoring tools and maintaining a stable flow of signals
* Ensuring the triage of the monitoring output, collaborating with relevant experts to assess impact to UCB
* Driving new and changed regulation implementation using a risk-based approach with relevant process owners and SMEs, tracking the execution by the business
* Editing GMP/GDP 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.
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