Make your mark for patients
To strengthen our Quality Auditing & Compliance department we are looking for a talented person to fill the position of: Global Quality Lead GCP Auditing & Compliance – Braine l’Alleud, Belgium
About the role
The Global Quality Lead for GCP Auditing & Compliance will develop and execute a GCP audit strategy, delivering a risk-based audit program to ensure the quality and compliance of UCB's GCP Quality Systems. This role ensures that UCB's clinical trials adhere to regulatory requirements, contractual agreements and UCB’s Global Quality Management System, effectively identifying and mitigating compliance risks.
You will work with
The Quality Organization, such as Early & Dev Solutions Quality Management, Quality Systems & Intelligence and other auditing teams within Quality Auditing & Compliance. Moreover, you will collaborate with stakeholders outside the Quality Organization, including Global Clinical Sciences & Operations, Global Clinical Development and Statistical Science & Innovation. Additionally, engagement with International Regulatory Authorities occurs through inspections.
What you will do
Internal & External Auditing
1. Develop and lead a risk based GCP audit program, assessing UCB’s quality system compliance
2. Conduct GCP audits per the annual program, including investigator sites, vendors and systems
3. Audit potential new vendors/partners for qualification before contracts
4. Prepare, support and follow up on external GCP audits, ensuring they align with UCB processes and standards
5. Manage audit findings, responses, and CAPAs in the Audit Management Tool, escalating issues as needed
Drive Insights for UCB through Data
6. Ensure timely and accurate audit data entry in the Audit Management Tool
7. Collaborate on issuing KPIs and dashboards for trend analysis and risk assessment across the GCP quality system
8. Provide data and feedback to internal stakeholders on quality/performance indicators and compliance status
Compliance Issues
9. Escalate GCP compliance concerns and provide expert guidance on CAPAs and quality improvements
10. Report critical compliance risks/issues to Quality Auditing & Compliance Leadership.
Consulting, Educating, Quality Improvement, and External Focus:
11. Leverage Regulatory Surveillance, Indrustry benchmarking, business, regulatory, and quality knowledge to influence quality approaches and ensure compliance with regulatory guidelines and UCB standards
12. Participate in medium- to long-term projects and lead improvement initiatives, including policy creation, training material development, and regulatory surveillance
Interested? For this position you’ll need the following education, experience and skills
13. Bachelor’s or Master’s degree
14. Substantial and broad-ranging experience in the pharmaceutical/biotechnology sector, including significant time in GCP-related areas
15. Required experience in Clinical Data Management and/or Biostatistics
16. At least 5 years of experience in auditing, and 5 years in clinical roles or a combination of both
17. Proven experience in leading a full range of GCP audits for internal processes/units and external partners or vendors
18. Proficient in applying regulatory requirements for the qualification, validation, implementation, use, and lifecycle management of digital systems, tools and applications
19. In-depth knowledge of ICH-GCP, applicable domestic and international regulations, quality principles and relevant business processes
20. High personal integrity with a commitment to patient welfare and ethical behavior
21. Fluent in English; additional languages are a plus
22. Willing to travel nationally and internationally, up to 30% of the time
23. Self-starter, reliable, positive, and able to manage workload and priorities effectively
24. Confident presenter and communicator, capable of representing the company and delivering clear messages to various audiences
25. Skilled negotiator, able to influence and gain cooperation from stakeholders, including senior management, during audits
26. Excellent planning and organizational skills with a structured approach
27. Builds strong internal and external partnerships
If you are interested to learn more about R&D within UCB, please find more information here .
RANDATUCB
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!