Spécialiste en assurance qualité
il y a 22 heures
We are looking for a Vendor Quality LeadLocation: Braine-l’Alleud, Belgium / HybridJob Type: Full-time Department: Global Quality AssuranceFor this position, knowledge in Chinese is a real asset The RoleWe are looking for a Vendor Quality Lead to provide strategic leadership and in-depth QA expertise for our complex Global Vendors (Contract Manufacturing Organizations - CMOs).In this role, you will be the driving force behind QA activities associated with GMP manufacturing for UCB Products. You will act as a key partner between UCB’s internal Quality management, Technical Operations, and our external manufacturing partners to ensure the highest standards of quality throughout the entire product lifecycle.Key ResponsibilitiesStrategic QA Point of Contact: Lead investigations, deviations, and out-of-specifications (OOS) for assigned vendors.Vendor Performance: Manage QA metrics (KPIs) and drive quality performance through recurrent vendor meetings and strategic reviews.Quality Agreements: Take full ownership of establishing and maintaining up-to-date Quality Agreements with global partners.Compliance & Product Oversight: Ensure Product Quality Reviews (PQR) and Annual Stability Programs are executed flawlessly and documented in our EDMS.Issue Resolution: Lead Root Cause Analysis for complex quality issues and coordinate Corporate Technical Review (CTR) meetings when necessary.Risk Management: Act as the primary QA stakeholder for Vendor Risk Management and challenge current practices to drive continuous improvement.Life Cycle Management: Oversee the product journey from Tech Transfer and commercialization to phase-out.Audits & Inspections: Monitor HA inspections and UCB audits at vendor sites, tracking CAPA implementation to ensure full compliance.Your ProfileEducation: Master’s Degree or Ph.D. in a scientific field (Pharmacy, Chemistry, Biology, etc.).Experience: Proven track record in the global pharmaceutical industry with deep knowledge of GMP regulations and business/technical operations.Expertise: Strong background in Root Cause Analysis and risk assessment/management.Leadership: Ability to influence senior internal and external stakeholders and manage projects across global geographies.Soft Skills: Excellent interpersonal and communication skills, with the professional maturity to handle complex, high-pressure situations.Languages: Fluent in English and knowledge in Chinese.
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