- Demonstrate deep understanding of global Regulatory Affairs and Quality regulations, industry best practices and technologies.
- Engage internal and external stakeholders, understanding, anticipating, and influencing the demand for services, translating requirements into efficient & aligned solutions.
- Design the demand management process, ensuring its smooth execution.
- Work in close collaboration with the regulatory & quality system owners to enable UCB IT strategy in both domains.
- Foster open communication and partnerships for enhanced stakeholder satisfaction and business objectives.
- Take responsibility for the Regulatory and QA applications, ensuring alignment with best practices, resilient operations and identifying efficiency opportunities.
- Drive digital transformation, identifying automation and insights opportunities, and managing change.
- Bachelor's or Master's degree
- Fluent in English.
- +3 years IT experience, preferably in global pharmaceutical or regulated industry, contributing with success to complex software implementation programs/projects.
- Broad understanding of Regulatory Affairs and Quality processes, workflows, and profound knowledge of drug development.
- Experience in electronic content document management (Veeva Vault, Vault administration certification is preferred), Publishing (DocuBridge), Supplier/Customer relationship management systems, Translation tools.
- System Administrator experience working with both Cloud (Saas) and on-premises applications.
- Technologically astute and having experience with REST API and application integration technologies.
- Technical skills: Java, JavaScript, SQL, XML, HTML, Postman, Curl, LibreOffice
- Other application skills: TomCat, Weblogic, PDF, Oracle, SQL Server, VMWare, Citrix, VDI, Ms Office Suite, CyberArk, Remedy Support systems & operating systems Windows, Unix, Linux.
- Strong project management skills, ensuring effective planning, execution, and monitoring within scope, time, and budget.
IT Solution Expert Regulatory - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
To strengthen our Information Technology team, based in Braine-l'Alleud, Belgium, or Raleigh, North Carolina, US, or UK, we are looking for a talented individual to fill the position of IT Solution Expert Regulatory & Quality
About The Role
This role has global responsibility for all IT systems that enable the Regulatory and Quality processes as defined by Regulatory Affairs and Quality leaders.
This role will ensure compliant, resilient, and secure operations of the Regulatory and Quality applications, will ensure compliant and secure system integrations with regulators, with the Regulatory & QA internal and external partners.
The geographical scope is global. It covers all the functional teams that span the global, local Regulatory Affairs, internal and external manufacturing, global QA. and other UCB teams as required.
All IT systems in this scope are GxP systems, subject to regulations, inspections, and audits.
What You'll Do
Interested? For this position you'll need the following education, experience and skills:
Why you should apply
Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward?
Join UCB's dynamic, inspiring and innovative environment and team. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.
Tell us what makes you the perfect match to our team and join one of the most dynamic & forward looking IT organizations in the world.
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
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