Loading...
Share this Job
Apply now »

 

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

Quality Partner Regional Quality

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  70409

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, we are looking for a talented individual to fill the position of: Quality Partner CoE.

 

As a UCB Regional Quality Partner CoE, you like to work in an environment where you can:  

  • Oversee the Quality Management System life cycle management for the world-wide UCB Affiliates (Europe & China, International Markets, Japan, and the U.S.) as part of the Regional Quality organization.
  • Be responsible for reporting on the QA deliverables and GxP status of the Affiliates in accordance with GXP, UCB and national legal requirements.

 

As a UCB Regional Quality Partner CoE, you will:

 

  • Maintain oversight of cross-regional data. e.g. approved vendor lists, vendor audits and self-inspection plans, marketed products, licenses, etc.
  • Tracking and follow-up of the quality compliance activities. e.g. Quality Reviews, Management Review, PQR, Mock Recall, Self-inspections, Vendor audits, etc.
  • Support implementation of the key Quality Indicators and Metrics as established by Global QA.
  • Operational support for training and systems.
  • Assure gaps identified through KQI's are addressed appropriately to mitigate risk and escalate critical trends to Regional Quality Heads.
  • Assure identified gaps between the local Quality Management System and the Global Quality Management System are properly addressed.
  • Provide expert support to the Regional Quality Heads for ensuring compliance of the local Quality Management System with the life cycle management of the Global Quality Management System. Identify opportunities for improvement and propose solutions.
  • Lead and coordinate the periodic Management Review of the Cross-Regional Quality Systems.
  • Ensure effective communication of all relevant quality matters identified, including issue escalation referring to QMS. 
  • Support Affiliates in QMS reporting activities to ensure inspection readiness.
  • Ensure that within the Affiliate the global and local GxP training programs are implemented, the content is compliant with global and local QMS, and implemented in the electronic training management system. Ensure efficient information flow and effective communication between the involved internal and external stakeholders.
  • Support the Quality Leads for Intercompany Quality Agreements or QAA where Affiliates are impacted (e.g. QAA with CMO/UCB annexes)
  • Support the Affiliate network as a SAP key user.
  • Support the Affiliate network as Qlik Sense key user.
  • Provide oversight of Regional QA process champions.
  • Support cross-regional projects on quality systems as needed.
  • Support local quality projects / issue resolution as needed.

 

 

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

  • Bachelor/Master’s degree
  • Minimum of 5 years working in the pharmaceutical industry in a GMP quality systems management position (QMS). Operational GxP experience would be a distinct advantage.
  • Familiar with processes and procedures within highly regulated environment.
  • High knowledge of technology/electronic systems world be a distinct advantage.
  • Have background knowledge of the pharmaceutical industry from a business and technical perspective.
  • Must be able to act in most circumstances without direct supervision and handle complex situations.
  • Must be able to effectively interact with different cultures/ geographies and internal and external personnel on many aspects of quality related matters.
  • Must have the ability to manage several projects/ activities in parallel within the area of expertise and demonstrate professional maturity in difficult situations.
  • Must possess excellent organizational skills along with interpersonal, verbal, and written communication skills at all levels internally and externally. Must speak English.
  • Have proficient knowledge of IT systems such as TrackWise, SAP, Documentation Management System, Microsoft Office tools (Teams, SharePoint, OneNote, Excel, PPT)
  • Must have the ability to independently analyze data and information to draw conclusions and propose actions.
  • Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrate initiative and the ability to help others solve problems in a creative and practical way.
  • Must be able to support colleagues through effective problem solving to ensure the best resolution is obtained.

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »