OverviewMake 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 RoleThis 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.What You Will DoParticipate 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.Education, Experience and SkillsBachelor’s, master’s degree or an education in a relevant scientific disciplineFluent 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 assetRoot 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.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!About UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.Why work with us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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