PpTo strengthen our bClinical Manufacturing Quality /b department we are looking for a talented profile to fill the position of: bDevelopment Quality Operations Data Integrity Partner – Braine l’Alleud, Belgium. /b /ph3About The Role /h3pAs part of Clinical Manufacturing Quality, you act as a Dev Quality Lab Ops Data Integrity Partner supporting CMC Development Sciences and Clinical Supply Chain entities. Your primary responsibility is to ensure the establishment, implementation, maintenance and continuous improvement of an effective Quality Management System (QMS) and robust Data Integrity practices across product development, from early clinical phases through to commercialization. This includes providing GMP oversight of laboratories at the Braine site in Belgium and GxP oversight of development entities across the Braine-l’Alleud and UK (e.g. Slough) campuses. /ph3You will work with /h3pIn this role, you closely support the Labs Dev Compliance Quality Lead by contributing to global quality oversight of clinical manufacturing and supply activities, working in close collaboration with both internal (Braine, Slough, Leuven) and external stakeholders. /ph3What You Will Do /h3ulliCompliance Support: Ensuring adherence to GMP/GDP regulations, health and safety guidelines. /liliData Integrity Management: Active participation in QA forums and lead meetings to manage Data Integrity (DI). /liliDocumentation Systems: Supporting and maintaining compliant documentation processes for UCB development activities. /liliIssued Copy Process: Acting as Reconciler to verify correct completion of the “issued copy” process and coordinating local instructions with stakeholders to maintain common practices. /liliTraining: Providing GMP/GDP expertise and data integrity training to customer department members. /liliQA Dev Compliance Oversight: Ensuring QMS compliance with regulations and policies, coordinating daily QA systems and DI activities. /liliData Integrity Governance: Leading CMC and CSC data integrity alignment, reviewing risk assessments, remediation plans, and effectiveness checks. /liliAudit Management: Coordinating audit preparedness, managing responses to audit observations including CAPA activities. /liliContinuous Improvement: Driving improvement opportunities related to QMS, Data Integrity, and Documentation Control; supporting digitalization initiatives. /liliStakeholder Interface: Acting as the operational link between QA-Systems, CMC Development, Clinical Supply Chain, IT, and QA-Management; preparing compliance, KPI, and risk summaries. /liliBackup Function: Serving as backup for the Dev Quality Lab Ops Partner to ensure continuity in QA Lab Oversight. /liliGuidance and Issue Resolution: Providing expert advice on GMP regulations, identifying and resolving compliance and quality issues to support training and improvements. /liliSupport for Development Quality Lead: Assisting with laboratory/manufacturing quality systems activities such as deviation closeout, change management, complaints, and quality improvement. /liliCoaching and Training: Delivering regular data integrity training and coaching across CMC Development and CSC entities /li /ulh3Interested? For this position you’ll need the following education, experience and skills /h3ulliBachelor’s, master’s degree or an education in a relevant scientific discipline /liliAt least 5 years’ experience in a QA regulated pharmaceutical environment /liliFluent in French and English communication (oral and written); any additional languages are a plus. /liliStrong knowledge of regulatory requirements (FDA, EudraLex, PIC/S, ICH) /liliExperience in audit and inspection support /liliExhibit effective communication skills when interacting with stakeholders /liliCapable of working independently and taking initiative /liliMust be able to act in most circumstances without direct supervision and handle complex/urgent situations. /liliAnalytical and problem-solving capabilities /li /ulpUCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. /ppShould you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. /p /p #J-18808-Ljbffr