{"id":3680216,"url":"https://alion.io/job/ucb-quality-management-system-qms-lead","title":"Quality Management System (QMS) Lead","company":{"id":1798748,"name":"UCB","domain":"ucb.com","url":"https://alion.io/company/ucb-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":{"grade":"A","score":85,"open_postings":5,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":23,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Braine-l'Alleud, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":true}],"status":"live","first_seen_at":"2026-11-03T09:03:07Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-04T03:56:19Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Make your mark for patients\nTo strengthen our Quality Management & Strategy department we are looking for a talented profile to fill the position of: Quality Management System (QMS) Lead- Braine l’Alleud, Belgium.\nAbout the role\nReporting directly to the Head of Quality Management System, the QMS Lead provides leadership and strategy to ensure the definition, development, implementation and lifecycle management of UCB’s Corporate Quality Management System.\nThe mission of the QMS Lead is to drive the development, implementation and maintenance of a Quality Management System framework that enables continuous improvement including innovation in design, approach and focuses adding value and maximizing agility, proactively provides emphasis on business efficiency for people, processes, and systems.\nYou will work with\nYou will work closely with senior leaders, functional QMS Leads, Quality Systems Leads, Process Owners and operational QA teams across the organization. Depending on the specific GxP scope, you will also collaborate with functions such as Global Regulatory Affairs, Patient Safety, S&TS, Clinical Development, Pharma Sciences, Biotech Sciences, Commercial Operations, Ethics & Compliance and IT. You will partner with these stakeholders to maintain and continuously improve the Quality Management System, identify and mitigate compliance risks, support regulatory inspections, drive process improvements and ensure alignment of Quality processes across the organization.\nWhat you will do\nQuality Management System\nDevelop and execute the strategy for the Corporate Quality system aligned with the overall UCB Patient Value Strategy and objectives.\nDevelops, designs and ensures that QMS remains current with respect to data integrity, data analytics and risk management (risk assessment and risk mitigation processes) whilst retaining the agility and flexibility of the processes within the QMS. \nEnsure its deployment, periodic review by senior management and lifecycle management by leveraging the Regulatory Intelligence Network process and industry benchmarking. \nManage and develop QMS lifecycle process as Quality QMS owner, taking into consideration the impact and involvement of ‘people, process and systems’.\nLead the specific QMS Governance, in alignment with the enterprise QMS framework.\nDevelop and launch QMS Maturity Program in close collaboration and agreement with senior management in Early Solutions/Development Solutions/Supply & Technology Solutions and maintain a QMS roadmap plan for the specific GxP scope QMS activities. \nDesign and build the architecture for Corporate Process Owner (CPO) governance embedded in the GxP CPO overarching governance. Provide leadership and guidance to the QMS Process Owners community within the Quality organization and the relevant business organizations, \nServe as single point of contact for all questions/process improvement initiatives/projects related to QMS. \nAssess the effort (resources, systems, organization …) and impact of any continuous improvements requests and/or additions of new processes to their QMS to prioritize the execution of the aforementioned aspects. \nOrchestrate and ensure continuous alignment with principles and ways of working of QMS across the different functional areas through engaging with key stakeholders, Functional teams and Process Owners. \nTraining QMS Deployment and Advisory\nDefine and develop the training strategy for specific GxP scope QMS its deployment together with the Head of DevSol Learning and business leaders.\nProvide guidance and expert advice to the organization, particularly regarding the appropriate interpretation of national and international specific GxP scope regulations and guidelines. \nAs QMS SME for specific GxP scope, where necessary work with relevant stakeholders to design, develop and deliver QMS-related training (& competency assessments).\nProcess and QMS Efficiency\nDefine and implement with Business QMS Leads process measurement metrics and maturity KPI to assess the maturity of the respective specific GxP scope QMS. \nRisk Management, Continuous Improvement and Change Management \nLead improvement initiatives, identified by senior management, to improve Quality Management processes, associated systems, stakeholder engagement and their effectiveness.\nFosters change management culture to facilitate adoption and usage of new ways of working.\nCollaborate and partner with functional units to identify and mitigate Compliance risks, resolve potential regulatory observations, escalate critical Compliance risks to upper management, and leverage internal resources and SME network to develop appropriate action plans and decisions as needed. \nQMS Documentation Framework \nMaintain strategic oversight of specific GxP scope QMS E2E Documentation Architecture (linking between processes/documents) and ensure the Enterprise standards are applied.\nOrchestrate and manage specific GxP scope QMS related Gap Analysis (GA) phase with functional QMS Leads for the impact to functional or local level documents (with a focus on processes, systems and people).\nAudits and Inspections\nProvide inspection support to health authority inspections and customers audits at UCB sites and inspections of UCB Quality Management Systems as needed and be point of contact for Process Owners. \nPartner and network with QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections. \nMaintain oversight of inspection and audit related CAPAs for QMS Processes.\nInterested? For this position you’ll need the following education, experience and skills\nBachelor’s, master’s degree or an education in a relevant scientific discipline\nFluent English communication (oral and written); any additional languages are a plus. \nDeep, sustained and current knowledge in and experience with Quality Systems in the regulated biopharmaceutical industry in Quality Management System and related operations (ie processes, systems, personnel). \nMaintains a comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation). \nA good and thorough understanding of current regulatory requirements and expectations (e.g. US, Europe, Japan, China) and an ability to interpret current regulations and requirements in the product development and clinical trials context is essential \nMust have excellent presentation skills and the ability to present content in an influential / compelling manner in front of senior management ·Works entirely independently with minimal supervision yet is a team player with and in a proactive approach. \nAbility to present complex projects and issues to senior management in a clear, succinct, coherent manner. \nNegotiation skills and a proven ability to influence senior leaders and others within a global matrix organization \nMust have the ability to adapt the delivery of message (ie strategy, process, training) to any audience, with an engaging, collaborative and influential manner.\nMust be knowledgeable of risk analysis techniques (FMEA, …), must be able to identify and evaluate risks and propose mitigation plans within complex situations \nProven analytical and investigation skills to understand global, complex Compliance and Regulatory issues \nExcellent planning and organizational skills with the ability to prioritize according to company priorities, Compliance and Patient Safety risk \nAre 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!\nAbout us\nUCB 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.\nWhy work with us?\nAt 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.\nAt 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.\nUCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.\nShould 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.","description_format":"text","description_chars":9039,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Belgium","iso":"BE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biologics & Biosimilars","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-03T12:46:39Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":23,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-11-04T05:24:40Z"},"pay":null,"html_url":"https://alion.io/job/ucb-quality-management-system-qms-lead","json_url":"https://alion.io/job/ucb-quality-management-system-qms-lead.json","meta":{"generated_at":"2026-11-04T05:24:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":8418,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1798748},"rest":"https://alion.io/mcp/rest/get_company?id=1798748"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fucb-quality-management-system-qms-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fucb-quality-management-system-qms-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fucb-quality-management-system-qms-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/ucb-quality-management-system-qms-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fucb-quality-management-system-qms-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3680216}},{"tool":"search_jobs","arguments":{"company":"ucb.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3680216},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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