Make your mark for patients
To strengthen our GMP/GSP Quality Operations department we are looking for a talented professional to fill the position of: Vendor Quality Lead Drug Product /QP – Braine l’Alleud, Belgium
About the role
This role supports the Qualified Person (QP) in batch release activities for Global products produced by third parties, including QA review of batch documents, issuing batch certificates, and transactional release. It involves pharmaceutical drug product release at UCB Pharma SA Belgium and deputizing for the QP during absences.
You will work with
The role also provides leadership and QA expertise in managing Quality Assurance activities with Global Vendors (CMOs) involved in GMP manufacturing for UCB products. This is done through collaboration with QA management at UCB, Product Global Quality Leads, Vendor Quality Leads, and UCB Technical Operations and other teams.
What you will do
Vendor Quality Lead (VQL):
1. Act as the main QA contact for investigations, deviations, out-of-specifications and audit observations with assigned vendors. Conduct QA reviews and collect supportive information for assessment
2. Manage and track key performance indicators for QA activities and services using defined tools
3. Ensure all quality agreements with vendors are in place, maintained and periodically reviewed
4. Ensure timely completion, review and documentation of Product Quality Review by vendors in the UCB Controlled Documents System.
5. Participate in regular vendor meetings as the QA representative, present issues and drive quality performance
6. Manage the follow-up and investigation of quality complaints with vendors and coordinate responses
7. Collaborate with the Vendor team and Global Quality Lead for root cause analysis and coordinate vendor quality-related investigations
8. Oversee UCB audits and Health Authority inspections related to vendors, track audit observations, and manage CAPA plans
9. Ensure review of relevant RA dossier section related to the assigned vendors
10. Cover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial, product improvements to phase out for the assigned vendors
Qualified Person (QP):
11. Perform the QA review of batch documents, assist the QP and issue batch certificates for product release and distribution.
12. Perform product release transactions in SAP and maintain the batch release register
13. Collaborate with Vendor Teams and CMOs to resolve document errors supporting release
14. Liaise with other departments and Affiliates to support the drug product release process and supply post-release documents
15. Assist Global Regulatory Affairs and Global Quality Leads with submission document requests
16. Review and approve Drug Substance and Drug Product specifications for global commercial products
17. Work closely with Technical Operations to ensure timely product disposition and effective QA services for commercial activities, including launches in new countries
Interested? For this position you’ll need the following education, experience and skills
18. It is mandatory to be Industrial Pharmacist and registered as Qualify Person from Belgian Health Authorities (registration number)
19. At least 5 years’ experience in GMP environment, manufacturing process for injectables (aseptic, post sterilizable, pre-filled syringes, lyo in vials) and quality systems (deviation, CC, OOS, complaints, …)
20. Experience in CMO management will be an additional strength as well as experience with regulatory submissions or auditing process
21. Must have excellent proficiency in English, both written and spoken. Ability to act independently and manage complex situations affecting multiple departments
22. Effectively interact with and influence senior internal and external stakeholders on project and product matters
23. Excellent interpersonal, verbal, and written communication skills, especially with senior management
24. Generate team commitment, encourage new ideas, and act as a role model
25. Skilled in operating in a multi-cultural environment
26. Analyze data independently, identify risks, propose corrective actions and develop innovative solutions through extensive quality experience
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!