IT Quality Management System Lead

Jobinhalt

Make your mark for patients

We are looking for an IT Quality Management System (IT QMS) Lead who is quality driven, enthusiastic mindset and natural strong communicator to join us in our IT Compliance team, based in our Braine L’Alleud office, Belgium

The IT QMS Lead provides leadership and strategy to ensure the definition, development, implementation, and lifecycle management of UCB’s IT Quality Management System.

The scope covers IT-related processes supporting GxP and non-GxP business processes, as well as corporate processes owned by the IT department and governing the implementation, usage, and maintenance of IT systems.

You will be the point of contact for the IT personnel with regards to understanding the impact of GxP regulation, business processes and impact on the IT processes and systems they own.

Who You’ll Work With

You will work within a team of highly skilled IT Compliance leads. You will collaborate closely with the IT System Owners, other QMS Leads across the organization, as well as with many stakeholders within UCB including Quality Assurance, IT Management, Process Owners…

What You’ll Do

• Develop and execute the strategy for the IT Quality Management System aligned with the overall UCB Patient Value Strategy, IT and Corporate objectives.
• Ensure the IT QMS deployment and lifecycle management by leveraging the Regulatory Intelligence Network process and industry benchmarking.
• Develop and launch an IT QMS Maturity Program in close collaboration and agreement with senior management in IT and Quality Assurance and maintain a QMS roadmap plan for the IT QMS activities.
• Maintain strategic oversight of overall IT Document management process and monitoring of these activities
• Provide guidance and expert advice to the IT organization, particularly with regard to the appropriate interpretation of national and international GxP regulations and guidelines impacting IT.
• Provide support to health authority inspections, internal and customers audits at UCB sites for the IT Quality Management Systems as needed
  
  

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

• Deep knowledge of IT processes (including IT infrastructure, system implementation, Change Management…) and their impact within and outside of IT department
• Good knowledge of regulatory requirements impacting IT such as GxP, Computerized System Validation, Data Integrity, IT System management within the pharmaceutical industry.
• Deep, sustained and current knowledge in and experience with Quality Management System in the regulated biopharmaceutical industry in particular specific GxP scope Quality Management System and related operations (ie processes, systems, personnel).
• Experience of +5 years in IT domain in the Life Sciences (Pharmaceutical, Medical Devices) or Healthcare industries.
• Knowledge of system development lifecycle (SDLC) processes.
• Strong communicator, Fluent in English (spoken and written)
  
  

Nice to have

• Experience in dealing with Regulators and Auditors, preparation and/or inspection and audit defense
• Experience with ITIL methodology
  
  

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.