Make your mark for patients
To strengthen our External Supply Quality DP department, we are looking for a talented profile to fill the position of: Vendor Quality Lead and Qualified Person (QP) – Braine l’Alleud, Belgium
About the role
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.
This position will support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.
Perform pharmaceutical drug product/finished good release at UCB Pharma SA Belgium as appropriate. This position will also deputize for the QP during absence or travel.
You will work with
This Vendor Quality Lead DP&QP will be closely partnering with QA management within UCB and at interfaces with CMC Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with UCB Technical Operations.
What you will do
Vendor Quality Lead (VQL) related accountabilities
1. Be the central QA point of contact for the organization for investigations/deviations/out-of-specifications/complaints/audit observations associated with the assigned vendors
2. Cover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
3. Ensure timely completion and, change controls, complaints, product quality reviews and support customer audits and Health Authority inspections
4. Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance
5. Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the vendors
6. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
7. Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Qualified Person related accountabilities
8. Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
9. Issue batch certificates for product release and distribution
10. Perform in SAP the transactional product release and maintenance of batch release register
11. Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
12. Maintain and report Metrics relating to batch release activities.
13. Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
Interested? For this position you’ll need the following education, experience and skills
14. Master’s degree in Industrial Pharmacy
15. QP certified number is required
16. Minimum 5-10 years of experience in the pharmaceutical sector with expertise in QA and injectables is required
17. Fluent English communication (oral and written); any additional languages are a plus.
18. Good background knowledge of the pharmaceutical industry from a regulatory, business and technical perspective.
19. Must be able to act in most circumstances without direct supervision and handle complex situations
20. Possess good auditing capabilities and skills.
21. Interact and influence senior internal and external stakeholders on many aspects
22. Must possess excellent interpersonal, verbal and written communication skills at all levels internally and externally especially at senior management levels.
23. Be able to coach, train and mentor colleagues and deliver training within area of expertise
24. Experience in operating in different cultures and in a multi-cultural environment
25. Expertise in root cause analysis and risk management
26. Ability to independently analyze data and information to draw conclusions and make effective decisions.
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!