UCB Braine-l’Alleud, Walloon Region, BelgiumJoin or sign in to find your next jobJoin to apply for the Vendor Quality Lead Drug Substance role at UCBContinue with Google Continue with GoogleUCB Braine-l’Alleud, Walloon Region, Belgium2 weeks ago Be among the first 25 applicantsJoin to apply for the Vendor Quality Lead Drug Substance role at UCBTo strengthen our External Supply Quality DS department, we are looking for a talented profile to fill the position of: Vendor Quality Lead Drug Substance – Braine l’Alleud, BelgiumAbout The RoleThis position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.You will work withThe VQL Drug Substance will be partnering with QA management within UCB and at interfaces with Product Global Quality Leads, Vendor Quality Leads for other vendor sites, and in collaboration with UCB Technical Operations and other UCB teams (Vendor Team, Extended Vendor Team).What You Will DoBe the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (UCB Vendor Team, GQL, ILA, ALO, Business) to allow assessmentManage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, Spider Impact) and track the vendor’s performanceEnsure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendorsWhen applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the UCB Stability ProgramEnsure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the UCB Controlled Documents SystemQuality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managedProvide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendorsWork closely with Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient wayCover the entire product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendorEnsure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)Have the overview of UCB audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendorManage and control quality documents related to the vendors in the UCB Controlled Documents SystemSupport on customer audits and Health Authority inspections at the vendors, as neededInterested? For this position you’ll need the following education, experience and skillsMaster’s degree preferably in biochemistry or engineeringSolid experience in the pharmaceutical industry - minimum 10 years - preferably in QAMinimum 4 years’ experience with biologicals, preferably within manufacturing and certainly in qualityFluent English communication (oral and written); any additional languages are a plusAbility to act in most circumstances without direct supervision and handle complex and sometimes difficult situationsPossess good auditing capabilities and skillsAbility to manage projects across global geographies within the area of expertiseBe capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for resultsExcellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levelsAbility to generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental and the company visionExperience in operating across cultures and in a multi-cultural environmentAre 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 around 8,500 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.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.Seniority levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical Manufacturing and Biotechnology ResearchReferrals increase your chances of interviewing at UCB by 2xSign in to set job alerts for “Quality Specialist” roles.Continue with Google Continue with GoogleContinue with Google Continue with GoogleSoignies, Walloon Region, Belgium 1 week agoTubize, Walloon Region, Belgium 2 weeks agoMechelen, Flemish Region, Belgium 1 day agoEvere, Brussels Region, Belgium 17 hours agoBrussels, Brussels Region, Belgium 2 weeks agoTubize, Walloon Region, Belgium 3 weeks agoEvere, Brussels Region, Belgium 3 days agoZaventem, Flemish Region, Belgium 2 days agoZaventem, Flemish Region, Belgium 4 days agoSoignies, Walloon Region, Belgium 4 weeks agoNivelles, Walloon Region, Belgium 5 days agoBraine-l’Alleud, Walloon Region, Belgium 5 days agoQuality Systems Senior Specialist (Change Control)Lessines, Walloon Region, Belgium 2 days agoBrussels, Brussels Region, Belgium 6 days agoBrussels, Brussels Region, Belgium 3 weeks agoBrussels, Brussels Region, Belgium 2 weeks agoEvere, Brussels Region, Belgium 17 hours agoQuality Engineer (H/F) - SAFRAN AIRCRAFT ENGINES SERVICES BRUSSELSZaventem, Flemish Region, Belgium 2 days agoSeneffe, Walloon Region, Belgium 1 week agoQuality Operations Equipment and Critical Utilities SpecialistLessines, Walloon Region, Belgium 2 weeks agoNivelles, Walloon Region, Belgium 1 week agoBrussels, Brussels Region, Belgium 3 days agoBrussels, Brussels Region, Belgium 1 week agoWe’re unlocking community knowledge in a new way. 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