Global Quality Lead
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

About UCB

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

To strengthen our Quality Assurance Group, we are looking to fill the position of: Global Quality Lead, Research & Clinical Development Quality Assurance.

What We Offer
An opportunity to:

• Partner with Development Science in facilitating the quality mindset into the research and clinical development portfolio across the UCB sites. 
• Provide direct compliance and investigative support to areas of research operations which are within the scope of the GLP Compliance Programme, the GCP Laboratories, the HTA Regulations and/or the Belgian Royal Decree on HBS.
• Provide guidance and support to Discovery Research in the implementation of basic principles of GRP.
• Occasionally travel internationally, up to 30%.

About the Role
Operating as the Vendor Manager for the team, you will be responsible for:

• Ensuring the maintenance of a comprehensive Research QA Vendor Management Programme for non-clinical QA services contracted to organisations that are regulated by GLP Regulations and GCP Laboratory Guidelines.
   

Additionally, you will be accountable for:

• Assessing the capabilities of potential vendors of non-clinical and ancillary services in GLP-regulated and GCP Laboratory activities at the local/global level.
• Ensuring multi-site study obligations including the Sponsor QA roles and responsibilities are met.
• Contributing to the maintenance and execution of a robust QA Programme to ensure ongoing GLP and GCP Lab compliance at the Braine site, and robust safety data in support of our UCB products.
• Partaking in the development and implementation of GRP principles.
• Partnering with Discovery Research to create ongoing training and awareness for the research teams on the importance of patent and intellectual property protection.

About You
You should be/have:

• A seasoned QA professional with a robust knowledge and understanding of the UK, EU and FDA regulations (GLP), as well as the UK/EMA GCP Laboratory Guidelines. 
• Working knowledge of GCP, HTA and HBS.
• Able to demonstrate the necessary attributes and behaviours for working with research scientists when discussing quality matters.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news