IT Solution Expert Regulatory & Quality

UCB

  • Braine-l'Alleud, Brabant Wallon
  • CDI
  • Temps-plein
  • Il y a 2 mois
Make your mark for patientsTo 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 & QualityAbout The RoleThis 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
  • 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.
Interested? For this position you’ll need the following education, experience and skills:
  • 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.
Why you should applyDo 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!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 with 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.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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

UCB