R&D and PV Vendor Quality Lead

R&D and PV Vendor Quality Lead

UCB - Union Chimique Belge

Braine L'alleud, Belgium

What you will do

• 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).
• Provide quality input into RFI/RFP/BID processes, including defining evaluation criteria, contributing to scoring, and supporting defensible vendor selection decisions.
• 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.
• 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).
• Support the Deviation & Escalation team (lead contact) by providing QA vendor management input for investigations, deviations, and audit observations associated with assigned vendors.
• Define, implement and maintain a risk-based vendor oversight model proportionate to vendor criticality and performance; establish governance cadence, meeting structures and escalation pathways.
• 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.
• 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

• Bachelor’s, master’s degree or an education in a relevant scientific discipline.
• Fluent English communication (oral and written); any additional languages are a plus.
• Training or formal education in Legal or Paralegal disciplines would be an advantage for this role.
• 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).
• 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.
• 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.
• 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.
• Root cause analysis and vendor risk management/assessment skills; continuous improvement mindset (lean/process mapping/workflow optimization).
• Integrity and objective professional judgment; operates largely independently and handles complex/difficult situations impacting multiple departments.
• Demonstrates strategic thinking and foresight by anticipating potential risks, recommending practical mitigation strategies, and driving sustainable compliance and performance enhancements.
• 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.
• Conducts independent analysis to derive sound conclusions and informed decisions; identifies risks and recommends appropriate corrective or preventive actions within their area of expertise.