Make your mark for patients
To strengthen our External Supply Quality DS department, we are looking for a talented profile to fill the position of: Vendor Quality Lead Drug Substance – 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.
You will work with
The VQL Drug Substance will be partnering with QA management within UCB and at interfaces with Product Global Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with UCB Technical Operations and other UCB teams (Vendor Team, Extended Vendor Team).
What you will do
1. Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (UCB Vendor Team, GQL, ILA, ALO, Business) to allow assessment
2. Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, Spider Impact) and track the vendor’s performance
3. 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 product GQLs and the vendors
4. When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the UCB Stability Program
5. Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the UCB Controlled Documents System
6. Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managed
7. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
8. Work closely with Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
9. 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 vendor
10. Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
11. Have the overview of UCB audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor
12. Manage and control quality documents related to the vendors in the UCB Controlled Documents System
13. Support on customer audits and Health Authority inspections at the vendors, as needed
Interested? For this position you’ll need the following education, experience and skills
14. Master’s degree preferably in biochemistry or engineering
15. Solid experience in the pharmaceutical industry - minimum 10 years - preferably in QA
16. Minimum 4 years’ experience with biologicals, preferably within manufacturing and certainly in quality
17. Fluent English communication (oral and written); any additional languages are a plus
18. Ability to act in most circumstances without direct supervision and handle complex and sometimes difficult situations
19. Possess good auditing capabilities and skills
20. Ability to manage projects across global geographies within the area of expertise
21. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results
22. Excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels
23. Ability to generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental and the company vision
24. Experience in operating across cultures and in a multi-cultural environment
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!