Make your mark for patients
To strengthen our Clinical Manufacturing Quality department, we are looking for a talented profile to fill the position of: Development Quality Lab Operations Partner – Braine l’Alleud, Belgium
About the role
As a Dev Quality Lab Ops Partner you will be ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development from phase I to commercialization. This position will directly support the Labs ＆ Dev Compliance Quality Lead to ensure proper oversight, from a global quality perspective of Analytical Dev Laboratories.
You will work with
This will be achieved through proactive and structured collaboration with key internal stakeholders across UCB sites in Braine, Slough, and Leuven, ensuring alignment on quality objectives and compliance requirements. In addition, the role will engage closely with external partners, particularly QA functions.
What you will do
The mains task for Quality System are :
1. Support all digital projects in CMC Dev a Business QA
2. Supplier qualifications, maintain the training material associated to it, ease the supplier qualification exercises for development activities. Ensure all information available in the different databases is up to date.
3. Deviation, CAPA and investigation management: liaise with dev key stakeholders all CMC entities (located in Braine, Slough) not limited to ADS, CSC, in order to maintain common practices with regards to deviation management, CAPA and Investigation within development entities
4. Change control management: liaise with dev key stakeholders, all CMC entities (located in Braine, Slough, Monheim) not limited to ADS, CSC in order to maintain common practices with regards to change control management within development entities
5. Management/annual review for Development entities all CMC entities: coordinate the development management review, ensuring principles mentioned in the associated corporate procedure are fulfilled for development entities
6. Internal audits management for Development entities all CMC entities, liaise with dev key stakeholders in order to maintain common practices with regards to internal audit within development entities, coordinate and update the development internal audit schedule, ensuring appropriate application of the audit planning. Act as co auditor for internal Audit.
7. Manage monthly Deviation/CAPA/Investigation/Change Control KPIs at Development: define with development stakeholders appropriate KPIs to be used on a monthly basis and during yearly management review exercises
8. Issue Copy: monitor KPIs related to their implementation
9. Participate in internal audits and self-inspections.
10. Provide comprehensive quality support to all relevant business functions.
11. Promptly identify issues and escalate them to the relevant management personnel.
12. Act as Business QA by offering support for both initial equipment qualification and regular reviews of validation status
13. Support as QA No-GMP activities
Interested? For this position you’ll need the following education, experience and skills
14. Bachelor’s, master’s degree or an education in a relevant scientific discipline
15. Minimum of five years’ experience in a Quality Assurance role within the pharmaceutical industry.
16. Fluent English communication (oral and written); any additional languages are a plus.
17. Knowledge of QA, QMS, and technical aspects of pharmaceutical development required
18. QA/Compliance experience in laboratory compliance and Quality Systems is an asset
19. Ability to work autonomously for the assigned activities with limited supervision
20. A good understanding of current regulatory requirements and Quality Standard (GMP, ICH, USP, WHO) and an ability to interpret current regulations and requirements in the product development and clinical trials context is essential.
21. Possessing specialised knowledge of data integrity regulations is considered a valuable qualification.
22. Demonstrated experience in conducting root cause analysis
23. Strong interpersonal skills, as well as excellent verbal, written, and presentation abilities are a must
24. Exhibits strong collaboration and leads projects efficiently, leveraging advanced organizational and analytical 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!