Make your mark for patients
To strengthen our Quality Systems & Governance we are looking for a talented profile to fill the position of: Data Integrity Quality Lead – Braine l’Alleud, Belgium.
About the Role
As a Data Integrity Quality Lead, you will provide leadership and strategy to ensure UCB’s Data Integrity Program is executed, maintained and followed. You’ll embrace new technologies like AI/ML and SaaS to ensure compliant data management across GxP processes, supporting global growth and maintaining compliance across regulatory requirements.
Who You Will Work With
You will work closely with the Head of GxP Data Integrity & Digital Compliance, Data Office, IT, Knowledge Management, and other key stakeholders. This role requires you to collaborate with cross-functional teams to address and mitigate data integrity risks and drive continuous improvement within UCB.
Ensure data integrity requirements are addressed across the entire biopharmaceutical life cycle – from pre-clinical, clinical, manufacturing, distribution and pharmacovigilance business operations.
What You Will Do
1. Assuring compliance with applicable and upcoming regulations and regulator’s expectations across GxP (GMP/GDP/GSP/GLP/GCP/ PhVP).
2. Enablement of continuous improvement including innovation in design and approach.
3. Focus on added value and maximizing agility.
4. Proactive provision on business efficiency for people, processes, and systems.
5. Supporting the constant inspection-readiness state.
GxP Data Integrity (GxP)
6. Support and promote the execution of the data integrity strategies at UCB.
7. Support and promote the execution of the data integrity roadmap.
8. Ensure robust data governance processes are established and maintained, including data quality management, data lifecycle management, and data risk management.
9. Collaboration and strategic alignment with cross-functional teams to identify and address data integrity risks. Identify gaps and develop appropriate mitigation plans.
10. Develop and deliver training programs on data integrity principles, practices, and regulatory requirements for all GxP personnel.
11. Serve as the primary point of contact for regulatory agencies and internal stakeholders on matters related to GxP data integrity.
12. Monitor industry trends and regulatory updates related to data integrity and ensure that the organization's practices remain compliant.
13. Support the Corporate Process Owner for GxP Data Integrity
14. Escalation point for critical data integrity issues to ensure those are managed in line with current data integrity expectations
15. Act as a local Data Privacy Officer for Quality and ensure personal data related to quality processes are managed in line with UCB and regulatory requirements on data privacy (GDPR…)
16. Author, review, and/or approve as appropriate Policies, SOPs, Deviations, Change Control, Complaints and other quality documentation related to Data Integrity
Consulting, Educating and External Regulatory & Industry Connectivity
17. Provide data integrity compliance consulting and education to ensure that the UCB network remains current with regulatory and industry trends.
18. Collaborate with and influence key stakeholders within UCB to collectively drive quality across the organization.
19. Lead or contribute to global quality projects and initiatives and promote internal and external collaboration to adopt new and enhance existing digital solutions.
20. Build the data & digital competency across GxP disciplines.
21. Participate in Global Industry Association(s) as UCB representative to contribute to standard setting (upcoming regulations, best practices) and benchmarking use of new technologies.
22. Cultivate internal and external network in order to maintain expert awareness of current regulatory thinking, trends, and benchmarking through key regulatory and industry relationships.
General
23. Lead transversal improvement initiatives identified by the Quality Lead Team to improve Quality Management processes, associated systems, stakeholder engagement and their effectiveness.
24. Fosters change management culture to facilitate adoption and usage of new ways of working.
25. Collaborate and partner with functional units to identify and mitigate Compliance risks, resolve potential regulatory observations, escalate critical Compliance risks to upper management, and leverage internal resources and SME network to develop appropriate action plans and decisions as needed.
26. Provide inspection support to health authority inspections at UCB sites and inspections of UCB Quality Management Systems as needed to maintain UCB’s Operations in accordance with Health Authorities issued regulations and communicated interpretations/expectations
Interested? For this role, we are looking for the following qualifications, experience, and skills:
27. Bachelor’s, master’s degree or an education in a relevant scientific discipline
28. Fluent English communication (oral and written); any additional languages are a plus.
29. Deep, sustained, and current knowledge in and experience with current GxP Data Integrity requirements
30. Proficient in Computer System Quality regulations
31. Familiar with new technologies that are part of the various digital transformation initiatives (SaaS, AI/ML, Open Source…) and the respective challenges and risks they pose
32. A good and thorough understanding of current regulatory requirements and expectations (e.g., US, Europe, Japan, China) and an ability to interpret current regulations and requirements is essential
33. Experience in managing various GxP Inspections across geographies, including inspector facing experience
34. Should possess outstanding presentation abilities and be capable of delivering content persuasively and effectively to senior management.
35. Negotiation skills and a proven ability to influence senior leaders and others within a global matrix organization
36. Must be knowledgeable of risk analysis techniques (FMEA, …), must be able to identify and evaluate risks and propose mitigation plans within complex situations
37. Demonstrates the ability to recognize and address critical issues, with escalation to executive management as necessary
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!