Make your mark for patients
To strengthen our Bio DS Quality department, we are looking for a talented profile to fill the position of: Quality System Specialist – Braine l’Alleud, Belgium
About the role
The Quality System Specialist will assist the Quality Bio DS Head to improve Quality Culture and to oversee compliance to both external regulations and internal procedures, policies and guidelines for UCB’s new commercial biologicals drug substance facility at our Braine campus.
This role is crucial in ensuring compliance with internal standards. The position also involves driving continuous improvement in quality processes to uphold the highest standards of product quality and safety. As this is a new facility, the role requires actively adapting to the challenges and realities of the initial years of operation.
You will work with
This position will collaborate with the Quality Bio DS Head and serve as her backup. Primary interactions will be with teams located in the new facility at both the QA and business levels. There will also be additional interactions with the corporate quality network.
What you will do
Regulatory Compliance
1. Support inspections or audits preparation by regulatory authorities, UCB Global Quality Auditing team, and others as needed (including development of responses).
2. Coordinate inspection readiness program.
Quality Governance
3. Prepare and lead the local Risk Management Committee; develop appropriate tools to collect quality-related risks and ensure escalation as per UCB quality management system.
4. Assist in preparing/leading the Quality Council; develop relevant indicators to assess maturity level and propose action plan to ensure continuous improvement and improve Quality Culture.
5. Act as a back-up for the preparation and leadership of quality governance boards (e.g., deviation review board, change control review board, etc.).
Quality System
6. Coordinate the local internal audit and self-inspection program, ensuring effective follow-up and driving continuous improvement.
7. Lead the assessment of documentation gaps and ensure alignment between global and local documentation by addressing identified discrepancies.
8. Maintain and review local quality system procedures (e.g., deviation management, internal audit, documentation control, etc.).
9. Implement and lead the annual local Quality System Reviews to monitor system performance and identify opportunities for improvement (e.g., deviation quality review, CAPA quality review, etc.).
10. Manage deviations and CAPA plans related to Quality Systems.
Quality Culture
11. Assist in the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff.
12. Represent the Bio DS Unit within corporate quality and compliance networks. Support network initiatives for local implementation; act as connection for global initiatives related to quality and compliance for local implementation.
Continuous Improvement
13. Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
14. Implement best practices and innovative solutions to improve product quality and operational performance.
Interested? For this position you’ll need the following education, experience and skills
15. Bachelor or Master’s Degree in science (Biotechnology, Chemistry, Pharmacist,)
16. At least 5 years’ experience proven background in quality systems or compliance
17. Demonstrated experience in biological drug substance (business and/or quality)
18. Proven experience in conducting audits and inspections is a added value
19. Strong communication skills effectively engaging with stakeholders
20. Demonstrated capability to collaborate effectively and influence stakeholders at all organizational levels and across departments
21. Capable of operating effectively in unpredictable environments and adapting to change
22. Consistently demonstrates composure in high-pressure situations
23. Proactively identifies challenges and takes decisive steps to address them and seeking effective solutions to improve outcomes
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!