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

Quality Lead in Gene Therapy

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65263

Gene Therapy Quality Leader

Quality, GxP 

Location: Braine L’Alleud, BE  
 
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 GxP Solutions Quality team, based in our Global QA offices in Braine L’Alleud, BE, we are looking to fill the position of: Gene Therapy Quality Leader . 


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 Gene Therapy Quality Leader  you like to work in an environment where you can:

• ensure the proper oversight, from a global quality perspective and across GxP of the UCB Gene Therapy/Advanced Therapy activities;

• represent QA within the UCB Gene Therapy team,  

• collaborate and negotiate with internal and external stakeholders in an international environment; 


As a UCB 'innoborative' person and Gene Therapy Quality Leader  you will contribute by: 
1. Lead the GxP QA activities supporting UCB Gene Therapy / Advanced Therapies initiatives

2. Be the single Quality Assurance Point of contact in the UCB Advanced Therapy team, supporting - and ensuring compliance - of the development of new processes and decisionmaking / governance. In order to do so, the incumbent will have to connect in and outside their own area of expertise within UCB.

3. Performing the QA evaluation transversally across the different GxP disciplines (GCP, GLP, GMP…) of Advanced Therapies external opportunities, relying on appropriate Subject Matter Expert where appropriate.

4. Ensuring the compliant progress, transversally across the various GxP disciplines (GCP, GLP, GMP…) of all the UCB internal Advanced Therapies initiatives.

5. Developing jointly with the Quality Management System Leads a compliant, fit-forpurpose, Quality Management System supporting the UCB Advanced Therapies initiatives.

6. Ensuring the development of Advanced Therapies expertise internally within UCB QA, by developing an internal Advanced Therapies learning pathway jointly with the QA Learning team

 

7. Establishing and maintaining Quality KPI of Gene Therapy initiatives

8. Performing Periodic Quality Management Review of Gene Therapy initiatives

9. Periodic update of quality status of Gene Therapies activities to UCB Quality Lead Team 


Interested? For this position you’ll need the following education, experience and skills: 
• Scientific Master degree or PhD (Medicine, Pharmaceutical, Biology…)

• Proficiency in Gene Therapy / Advanced Therapies pharmaceutical environment and corresponding regulatory requirements is a must 

 

• Minimum 15 years experience in the Pharmaceutical Industry:

- Including at least 5 years prior experience in Gene Therapy / Advanced Therapies pharmaceutical environment

- Including at least 5 years prior experience QA position

- Experience in direct interaction with authorities (Inspectorate and/or Reviewers) regarding Gene Therapy activities  

 

• Fluency across disciplines beyond your own, and be able to connect in and outside your own area of functional expertise.  

• Curious, flexible, entrepreneurial, collaborative and goal-oriented

• Ability to register as an EU Qualified Person is an asset

• Must be able to communicate fluently in English to various level of the organization, including Executives 
 


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