Social network you want to login/join with:Early & Clinical Development Quality Lead, Braine-l'Alleudcol-narrow-leftClient:UCBLocation:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:1ec6eca6f1f6Job Views:3Posted:06.05.2025Expiry Date:20.06.2025col-wideJob Description:Make your mark for patientsTo strengthen our Quality department, we are looking for a talented professional to fill the position of Early & Clinical Development Quality Lead – Braine l’Alleud, BelgiumAbout the roleAs part of the UCB Quality organization, the Early & Clinical Development Quality Lead (ECDQL) actively promotes quality and GLP, GCP, GVP compliance during the early development, clinical development, and post-marketing phases of UCB compounds at a global level. Collaborating with internal teams and external stakeholders, the ECDQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness.You will work withYou will work closely with various internal functions within Quality and the Business areas you support. Additionally, you will engage with external partners and vendors to ensure compliance.What you will doDevelop and maintain the Quality Strategy at a compound levelCreate and sustain a quality roadmap for strategic quality objectives, covering clinical development and post-marketing phasesIdentify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendorsEnsure compliance with GxP regulations, guidance, and internal procedures while reducing complexityProactively identify opportunities to de-risk at a compound levelPlan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulationsLead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits, and inspectionsEscalate issues early and ensure effective resolution or measures are in placeLead or contribute to complex projectsManage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.Monitor performanceConduct analytics and qualitative assessments to identify trendsMonitor quality deliverables from vendors and partners, sharing updates with internal functionsEnsure continuous inspection readiness and integrity of the data included in regulatory dossiersSupport inspections and investigations, coordinating responses and hosting strategiesGCP/GLP/GxP Quality Advisor ResponsibilitiesReview and implement updates to GxP legislation, define best practices, and assess the impact on procedures, systems, and contractual arrangementsProvide expert advice to mitigate compliance risks or address complex issuesDeliver presentations to peers, senior management, and industry audiencesInterested? For this position, you’ll need the following education, experience, and skills:Bachelor's degree in a relevant scientific or healthcare-related fieldMinimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research, clinical development, or PharmacovigilanceProficient in research/GLP, GCP, and/or GVP regulationsAbility to translate regulatory and quality expectations into operations, based on knowledge of quality principlesExperience in GLP, GCP, and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an assetAbility to drive collaboration and engagement across stakeholder networks, motivating others to achieve resultsSkilled in influencing within a global matrix organization and driving informed decisionsCapable of prioritizing critical issues using a risk-based approachManages quality and compliance issues with diligence, rigor, transparency, and timelinessStrong analytical skills with experience in analyzing and synthesizing complex dataProficient in presenting complex projects and issues clearly and succinctlyExpertise in managing transversal quality optimization projects and resolving complex issuesExcellent planning, organizational, presentation, training, communication, and interpersonal skillsProficient in MS Office Suite; experience with statistical programs, SAP, and Veeva is an advantageIf you are interested in learning more about R&D within UCB, please find more information here.RANDATUCBAre 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!
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