Make your mark for patients
We are looking for a Data Integrity Quality Lead who is proactive, strategic, and highly skilled to join our Data Integrity & Digital Compliance team, based at our UCB campus located in 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 the 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. Lead the execution and maintenance of UCB’s data integrity strategies.
2. Develop and deliver training on data integrity for all GxP personnel.
3. Collaborate with teams to identify and address data integrity risks.
4. Support during inspections from regulatory agencies related to digital and data integrity topics.
5. Ensure continuous improvement in data governance and risk management processes.
6. Act as a consultant on data integrity practices and regulatory requirements.
7. Support the Corporate Process Owner for GxP Data Integrity.
Interested? For this role, we are looking for the following qualifications, experience, and skills:
8. Proven experience in GxP Data Integrity and Computer System Quality regulations.
9. Strong background in data integrity regulatory requirements related to computerized system compliance across global markets (US, Europe, Japan, China), paper-based systems and hybrid models.
10. Experience in managing GxP inspections and addressing critical compliance issues.
11. Ability to communicate and collaborate effectively with senior management and cross-functional teams.
12. Knowledge of emerging technologies (SaaS, AI/ML) and their regulatory impact.
13. Fluent in English with excellent presentation and negotiation skills.
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!