Make your mark for patients
To strengthen our Global Quality Auditing department, we are looking for a talented profile to fill the position of: Global Quality Lead Technology Auditing – Braine l’Alleud, Belgium.
About the role
The Global Quality Lead Technology Auditing role requires a highly skilled professional specializing in audits of Computer Systems Validation (CSV), IT compliance, and Data Integrity within the biotech and pharmaceutical industry. The ideal candidate will have a strong background in GxP-regulated environments, demonstrate deep knowledge of FDA, EMA, and other global regulatory requirements, and ensure that computerized systems meet the highest standards of compliance, security, and quality. They identify and mitigate compliance risks through global auditing, setting quality standards, monitoring regulatory trends, and educating teams. Effective communication and organizational skills are essential for identifying gaps, assessing risks, and aligning stakeholders and senior management on potential issues. The role is based in the EU and will require on average 30-35% travel on a global basis.
You will work with
This role will work closely with the Head of Quality Auditing and Supply and Technical Solutions, as well as collaborating with internal teams across Pharma, Bio, Gene Therapy, and Medical Device divisions. They will also engage with external auditors and regulatory bodies to ensure compliance. Additionally, the role involves frequent interaction with stakeholders and senior management to address compliance risks and align risk mitigation strategies.
What you will do
Internal & External Auditing/Inspections
1. Support the creation and maintenance of the Technology Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
2. Support the Technology Global Audit Program through the execution of Due Diligence, Qualification, Routine, and For Cause audits including Mock Inspection exercises, Pre-approval or Routine inspection assistance as assigned per senior management,
3. Ensure the follow up on the above-mentioned audits or inspections, as well as timely CAPA closure, including continuous improvement related to Quality Auditing metrics,
4. Build data & digital competency for the UCB auditors across GxP disciplines by providing dedicated training, feedback, and creation of training material.
5. Support the development and execution of the Auditor Qualification Program
Consulting, Educating, Quality Improvement, and External Focus
6. Provide Technical and Compliance guidance as a member of selected committees,
7. Lead improvement initiatives, identified by Senior Management, in-order to improve Corporate QA processes and effectiveness,
8. Partner with the UCB Network QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections, as deemed necessary and which may include on-site or remote inspection support activities and/or training,
9. Function as an in-house Consultant and Educator to keep abreast of regulatory and industry trends: Share key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards.
Compliance Issues
10. Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
11. Escalate as identified any critical Compliance or Patient Safety risks to upper management,
12. Leverage internal resources and SME network to develop appropriate action plans and decisions as needed
Interested? For this position you’ll need the following education, experience, and skills
13. Master’s or Bachelor’s degree in a relevant scientific discipline (Computer Science, Bioinformatics, Engineering, or related science)
14. Fluent in English (speaking & writing); additional languages are a plus
15. Minimum 5-10 years of experience in software development lifecycle, computerized systems validation, or equivalent role within a GxP-regulated environment
16. Willing to travel internationally up to 35% of the time
17. Strong understanding of FDA, EMA, GxP, GDPR, and other relevant regulatory frameworks.
18. Proven experience providing quality oversight for laboratory systems, IT systems, and QMS platforms, ensuring validation activities comply with regulatory requirements and internal policies.
19. Demonstrated ability to establish and maintain governance frameworks for validation lifecycle management, including system risk assessments, validation planning and execution, testing and periodic reviews.
20. Firsthand experience developing and implementing strategies for computer systems validation, ensuring alignment with industry standards, regulatory expectations, and company procedures.
21. Strong background in Data Integrity compliance, including application of ALCOA principles across computerized systems and supporting remediation activities.
22. Experience leading and managing CAPA processes from initiation through closure, ensuring timely and effective resolution.
23. Proven history in inspection readiness activities, including preparation for regulatory audits and internal inspections.
24. Familiarity with IT best practices, IT Security, and compliance with GDPR regulations.
25. In-depth understanding of Quality Systems as they relate to GxP activities and computerized systems.
26. Ability to interpret and apply regulatory requirements to complex IT and validation scenarios.
27. Excellent leadership, communication, and collaboration skills to work effectively across functional teams.
28. Knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and other electronic records/electronic signatures regulations.
29. Certification in CSV, Data Integrity, IT, or Auditing is a plus.
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!