Make your mark for patients
To strengthen our Quality department, we are looking for a talented professional to fill the position of: Early & Clinical Development Quality Lead – Braine l’Alleud, Belgium
About the role
As part of the UCB Quality organization, the Early & Clinical Development Quality Lead (ECDQL) actively promotes quality and GLP GCP GVP compliance during the early development, clinical development and post-marketing phases of UCB compounds at a global level. Collaborating with internal teams and external stakeholders, the ECDQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness.
You will work with
You will work closely with a variety of internal functions within Quality and the Business area’s you support, Additionally, you will engage with external partners and vendors to ensure compliance.
What you will do
Develop and Maintain the Quality Strategy at a Compound Level
1. Create and sustain a quality roadmap for strategic quality objectives, covering the clinical development and post-marketing phases,
2. Identify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendors
3. Ensure compliance with GxP regulations, guidance, and internal procedures while reducing complexity
Proactively Identify Opportunities to De-Risk at a Compound Level
4. Plan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulations
5. Lead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspections
6. Escalate issues early and ensure effective resolution or measures are in place
7. Lead or contribute to complex projects
8. Manage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.
Monitor Performance
9. Conduct analytics and qualitative assessments to identify trends
10. Monitor quality deliverables from vendors and partners, sharing updates with internal functions
11. Ensure continuous inspection readiness and integrity of the data included in regulatory dossiers
12. ead/support inspections and investigations, coordinating responses and hosting strategies
GCP/GLP/GxP Quality Advisor Responsibilities
Review and implement updates to GxP legislation, define best practices and assess the impact on procedures, systems and contractual arrangements
13. Provide expert advice to mitigate compliance risks or to address complex issues.
14. Deliver presentations to peers, senior management, and industry audiences
Interested? For this position you’ll need the following education, experience and skills
15. Bachelor's degree in a relevant scientific or healthcare-related field
16. Minimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research, clinical development or Pharmacovigilance.
17. Proficient in research/GLP, GCP and/or GVP regulations
18. Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles
19. Experience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset
20. Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results
21. Skilled in influencing others within a global matrix organization and driving informed decision-making
22. Capable of prioritizing and focusing on critical issues using a risk-based approach
23. Manages quality and compliance issues with diligence, rigor, transparency and timeliness
24. Strong analytical skills with experience in analyzing and synthesizing complex data
25. Proficient in presenting complex projects and issues clearly and succinctly
26. Expertise in managing transversal quality optimization projects and resolving complex issues
27. Excellent planning, organizational, presentation, training, communication and interpersonal skills
28. Proficient in MS Office Suite; experience with statistical programs, SAP and Veeva is an advantage
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!