Make your mark for patients
To strengthen our R&D and PV Vendor Quality department, we are looking for a talented profile to fill the position of: R&D and PV Vendor Quality Lead – Braine l’Alleud, Belgium
About the role
This position provides leadership and in-depth Quality Assurance (QA) expertise to drive strategic and operational QA activities associated with Vendors engaged in preclinical (GLP), clinical (GCP) and post-marketing pharmacovigilance (GVP) activities relating to Sponsor and/or MAH obligations on a global scale.
The Vendor Quality Lead (VQL) reports to the Head of R&D and PV Vendor Quality and takes responsibility for the activities for the vendors assigned, ensuring inspection readiness, robust contractual language (e.g., Quality Agreements), risk-based oversight and sustainable vendor performance.
You will work with
The role ensures end-to-end vendor quality governance across the vendor lifecycle (selection, qualification, oversight, performance improvement and transition/termination). This will be achieved through close partnering with Global QA management within UCB, Quality Leads focusing on preclinical (GLP), clinical (GCP) and post-marketing (GVP) compliance, GMP/GDP Vendor Quality Leads for vendors operating in the interface, Corporate Process Owners, Procurement, Legal, Digital/IT, and other internal UCB Teams and stakeholders, delegating activities to selected Vendors, and through direct engagement with vendor organizations (vendor QA and operational leadership) to drive governance, performance improvements, and inspection readiness.
What you will do
1. Participate in the assessment and qualification of Vendors supporting preclinical (including but not limited to GLP), clinical (GCP) and/or post-marketing pharmacovigilance (GVP) activities (including Digital/IT and eClinical vendors where GxP applicable).
2. Provide quality input into RFI/RFP/BID processes, including defining evaluation criteria, contributing to scoring, and supporting defensible vendor selection decisions.
3. After vendor qualification, ensure handover of the qualification package (incl. system/data integrity expectations/evidence) to the relevant QL(s) for routine oversight, coordinating with IT/CSV (validation execution) to confirm validation readiness/go-live evidence; for any new or materially changed GxP-relevant system introduced later, ensure documented handover of implementation/go-live evidence with agreed monitoring points, escalation pathways and periodic review
4. Ensure Quality Agreements are in place and take ownership of agreements for the vendors assigned (creation support, negotiation input, periodic review, update, closure and archiving). Ensure post-marketing GVP responsibilities and governance expectations are explicit (e.g., escalation timelines, data exchange, subcontractor controls, record retention, audit rights).
5. Support the Deviation & Escalation team (lead contact) by providing QA vendor management input for investigations, deviations, and audit observations associated with assigned vendors.
6. Define, implement and maintain a risk-based vendor oversight model proportionate to vendor criticality and performance; establish governance cadence, meeting structures and escalation pathways.
7. Provide expert QA advice, support and management for technical operational QA and general QA matters associated with vendors; work closely with Corporate QA teams, functional areas and affiliates across geographies.
8. Be a Best Practice ambassador and lead best practice/harmonization initiatives across the company, as assigned.
Interested? For this position you’ll need the following education, experience and skills
9. Bachelor’s, master’s degree or an education in a relevant scientific discipline
10. Fluent English communication (oral and written); any additional languages are a plus.
11. A minimum of 8–10 years of proven experience in preclinical (GLP), clinical (GCP), and post-marketing pharmacovigilance (GVP), with demonstrated expertise in the practical application of relevant regulations and guidelines (EMA/FDA/ICH; OECD GLP principles, as applicable).
12. Strong vendor lifecycle quality expertise: risk-based qualification and auditing/assessment planning & execution; deviation management; CAPA lifecycle and verification of effectiveness; Quality Agreement lifecycle management.
13. Data integrity mindset and awareness of electronic system validation considerations relevant to vendor services, including GxP-relevant Digital/IT platforms and eClinical systems, where applicable.
14. Demonstrated experience with digitalization/automation/Artificial Intelligence-driven (AI) technologies and a strong inclination toward leveraging such technological solutions to enhance processes and decision-making is a great asset
15. Root cause analysis and vendor risk management/assessment skills; continuous improvement mindset (lean/process mapping/workflow optimization).
16. Integrity and objective professional judgment; operates largely independently and handles complex/difficult situations impacting multiple departments.
17. Demonstrates strategic thinking and foresight by anticipating potential risks, recommending practical mitigation strategies, and driving sustainable compliance and performance enhancements.
18. Actively supports the professional development of colleagues by sharing best practices and contributing to the cultivation of top talent; navigates effectively in diverse, multicultural environments.
19. Conducts independent analysis to derive sound conclusions and informed decisions; identifies risks and recommends appropriate corrective or preventive actions within their area of expertise.
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!