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 Auditing GMP – Braine l’Alleud, Belgium
About the role
The Global Quality Lead Auditing GMP ensures UCB’s Pharma, Bio, Gene Therapy and Medical Device activities comply with current GMP/GDP standards and internal policies. They identify and mitigate compliance risks through global auditing, setting quality standards, monitoring regulatory trends and educating teams. Strong communication and organizational skills are essential for identifying gaps, assessing risks, and aligning stakeholders and senior management on potential issues.
You will work with
This profile will work closely with the Head of Quality - Auditing and Compliance Supply and Technical Solutions, as well as collaborate 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 on risk mitigation strategies.
What you will do
Internal & External Auditing/Inspections
1. Support the creation and maintenance of the Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
2. Support the Global Audit Program through the execution of Due Diligence, Qualification, Routine GMP/GDP 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. Support the development and execution of the Auditor Qualification Program
Consulting, Educating and External Focus
5. Provide Technical and Compliance guidance as a member of selected committees,
6. Lead improvement initiatives, identified by Senior Management, in-order to improve Corporate QA processes and effectiveness,
7. 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,
8. 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
9. Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
10. Escalate as identified any critical Compliance or Patient Safety risks to upper management,
11. 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
12. Master’s degree or bachelor’s degree, certified Auditor or Quality Professional (e.g., ASQ) – certifications are preferred but not required
13. Fluent in English (speaking & writing); additional languages are a plus
14. Minimum 10 years of experience in Quality Assurance, focused on Biopharmaceuticals/Advanced Therapies
15. Deep expertise in Drug Substance and/or Drug Product manufacturing for pharma/biopharma drugs
16. Preferred knowledge/experience in Combination Product and Device QMS and regulatory frameworks
17. Aseptic Processing/Sterile Manufacturing/Gene Therapy/Advanced Therapy expertise is preferred
18. Extensive auditing experience, either as Auditor or Auditee
19. Strong asset: Experience in regulatory inspections (FDA, ANVISA, KFDA, EMA, etc.)
20. Comfortable with new technologies beyond basic IT tools (e.g., Office, Veeva), including virtual/augmented reality, AI, etc.
21. Proficient in Audit Management Tools (e.g., TrackWise, Veeva)
22. Excellent presentation, training, analytical, and investigation skills
23. Willingness to travel globally up to 30-35%
24. Analytical mindset to understand complex global Compliance and Regulatory issues
25. Strong negotiation skills with proven ability to influence within a global matrix organization
26. Excellent planning, organizational skills, and ability to prioritize based on Compliance and Patient Safety risks
27. Effective in handling stressful situations, driving issue resolution, and escalating critical issues to Senior Management when needed
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!