Make your mark for patients
To strengthen our Solution Quality department we are looking for a talented profile to fill the position of: Solutions Quality Lead – Braine l’Alleud, Belgium
About the role
This position will consist in creating value by contributing to quality directions and insights that protect patients and ensure sustainable compliance. The new team member will participate in inspection readiness activities for real-time readiness and preserve UCB’s reputation in early pharmaceutical development. They will also provide quality support to research and clinical operations within the scope of GLP, GCP, and HTA/HBS Compliance Programs, ensuring the implementation and maintenance of UCB quality standards and policies within Patient Solutions.
You will work with
In this role, you will work closely with various stakeholders across multiple functions. You will collaborate with Global Quality Auditing, Quality Systems & Governance, business stakeholders within Research, External Innovation and Operations and Early Clinical Development and Translational Sciences and additional transversal UCB communities. Your role will involve contributing to process improvements, ensuring alignment with UCB Policies and Procedures and regulatory requirements.
What you will do
Process Improvement Contributor
1. Evaluate updates to global regulations to identify changes needed and implement through change control process of UCB Policies, SOPs and related controlled documents related to GLP and GCP
2. Contribute to and/or review procedural documents according to UCB Policies and Procedures relating to GLP activities in Policies, SOPs and related controlled documents to ensure applicable regulatory requirements
3. Develop and maintain a high level, digital process landscape for all standard operating procedures by using process mapping software to visualize the end-to-end processes across discovery, development, and delivery stages to support data driven decision making.
Inspection Readiness Management Contributor
4. Support and/or function as a liaison during GLP/GCP/HTA inspections and investigations conducted by international and national authorities or business partners according to UCB Policies and Procedures
GCP/GLP/GxP Quality Contributor
5. Utilize knowledge and understanding of applicable regulations and quality principles to collaborate effectively and ensure work products and outputs are aligned with OECD GLP regulations, ICH guidelines, Human Tissue Regulations, and any other applicable regulatory requirements or UCB global quality standards.
6. Conduct and/or collaborate in the delivery of data analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.
7. When requested, lead and/or participate in Quality Initiatives
Other Responsibilities
8. When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributor
9. Participate in the delivery of presentations to peers and as requested, senior management
10. When requested, provide mentoring and guidance to other members of the R&D and Pharmacovigilance Quality team.
Interested? For this position you’ll need the following education, experience and skills
11. Bachelor’s, master’s degree or an education in a relevant scientific discipline
12. 5 to 8 years’ of relevant experience in the pharmaceutical industry
13. Previous experience with GLP and GCP is considered a strong asset
14. Fluent English communication (oral and written); any additional languages are a plus
15. Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results
16. Skilled in influencing others within a global matrix organization and driving informed decision–making
17. Capable of prioritizing and focusing on critical issues using a risk-based approach
18. Demonstrate strong analytical skills with experience in analyzing and synthesizing complex data
19. Proficient in presenting complex projects and issues clearly and succinctly
20. Expertise in managing transversal quality optimization projects and resolving complex issues
21. Excellent planning, organizational, presentation, training, communication and interpersonal skills
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!