🇳🇱 Leiden, Netherlands · 16h ago
Technical Expert eLIMS CoE QC Operations
Johnson & Johnson MedTech
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job FunctionQualityJob Sub FunctionQuality SystemsJob CategoryProfessionalAll Job Posting Locations:Horsham, Pennsylvania, United States of America, Leiden, South Holland, Netherlands, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Ringaskiddy, Cork, Ireland, Schaffhausen, SwitzerlandJob DescriptionPosition Summary & Essential Job Duties and ResponsibilitiesPosition SummaryThe Analyst eLIMS CoE, QC Operations, is responsible for the independent configuration, governance, and lifecycle management of complex master data within the eLIMS (LabVantage) system.The role ensures that system configurations are accurate, compliant, and aligned withbusiness and regulatory requirements. The position applies advanced system and process knowledge to translate complex requirements into effective configurations and supports the continuous improvement of QC laboratory operations within a regulated (GxP) environment.The Analyst operates with a high degree of autonomy, takes ownership of assigned domains, and acts as a subject matter expert (SME) for site-specific and cross-functional processes.The Analyst will escalate issues whenever required and understand the impact towards our customers when changing / updating existing Master Data.AccountabilitiesEnsures accuracy, completeness, and compliance of complex master data within eLIMSDrives harmonized and standardized system configurations across sites and processesLeads and executes change control activities, including impact assessments and implementationMaintains inspection-ready documentation across systems (eLIMS, EDMS, etc.)Acts as subject matter expert (SME) for assigned domains (e.g., Release, Stability)Identifies and drives process improvements and optimization initiativesEnsures timely and coordinated resolution of complex issues across multiple stakeholdersEnsures accuracy, completeness, and compliance of master data within eLIMSEssential Job Duties And ResponsibilitiesMaster Data Management (50-60%)Independently create, review, approve, and maintain complex master data in eLIMS (LabVantage)Configure and maintain master data related to:Release processesStability studiesRaw Materials (RM)Packaging Materials (PM)Certificate of Analysis (COA)Ensure all configurations:Meet defined data standards and design structuresAre accurate, complete, and compliantManage and coordinate master data requests across multiple sites within Base Business operationsSupport and maintain Stability Master Data Management across sites, where applicableSupport maintenance of Common Specifications and cross-site harmonizationTranslate complex business requirements into system configurationsApply advanced understanding of paperless laboratory processes and master data design filesQuality Systems & Compliance (20-30%)Support Non-Conformance (NC) and Correctiva Action / Preventive Action (CAPA) processes within the Enterprise Quality Management System (e.g., COMET)Act as Change Control Assessor:Evaluate change requests for system and cross-functional impactAct as Change Control Executor:Implement approved changes within eLIMS and related systemsParticipate in:Pre-CoC / kick-off discussionsPlanning and execution of change implementationsEnsure compliance with:Internal procedures (SOPs, WIs)Regulatory requirements (cGMP, GxP)Maintain and update system-related documentation in EDMS, ensuring:AccuracyTraceabilityVersion control complianceProject Support & Continuous Improvement (15-20%)Support and contribute to system-related projects, including:System upgradesEnhancementsNew implementations (e.g., iLABs, NPIs)Perform and/or support User Acceptance Testing (UAT) activitiesAct as interface between iLABs Base Business / project teams and automation initiativesIdentify inefficiencies and drive process improvementsPropose and implement optimization initiatives within master data and system processesMay act as Process Owner (PO) for defined processes (e.g., Release, Stability)Data Management & Reporting (up to 10%)Utilize approved analytical tools (e.g., Tableau, Power Automate) for:Data extractionReportingAutomation and process efficiency improvementsSupport data-driven decision-making and process monitoringScope & InterfacesComplex eLIMS (LabVantage) master data configuration and governanceMulti-site QC environmentsCross-functional and global operationsKey InterfacesQC Operations / Laboratory teams (multi-site)Quality Assurance / Quality SystemseLIMS CoE / System OwnersIT / Digital / Automation teamsCross-functional stakeholders (e.g., Manufacturing, Supply Chain)Minimum QualificationRequiredBachelor’s degree or equivalent combination of education and experience2–4 years of experience in a regulated environmentHands-on experience with eLIMS (LabVantage)Solid knowledge of:cGMP / GxP requirementsQuality systems and compliance processesRisk management principlesDemonstrated ability to:Manage complex topics independentlyPrioritize and organize effectivelyEscalate appropriatelyStrong communication skills in English (minimum B2; C1 preferred)Proven ability to work independently and lead domain-specific initiativesStrong stakeholder management and cross-functional collaboration skillsPreferredOther requirementsAdvanced experience in eLIMS master data configuration (multiple data types)Strong understanding of:iLABs / paperless lab processesNew Product Introduction (NPI) workflowsExperience with:Stability Master Data ManagementCOA configurationProficiency in Enterprise Quality Systems (e.g., COMET)Experience in Change Control (assessment and execution ownership)Experience with EDMS (e.g., TruVault)Understanding of multi-site configurations (Biotherapeutics, Synthetics, Advanced Therapies)Core CompetenciesAdvanced analytical thinkingHigh attention to detailStructured problem-solvingStrong ownership and accountabilityStakeholder influence and collaborationAbility to manage complexity in regulated environmentsundefinedAt Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.Here’s What You Can ExpectApplication review: We’ll carefully review your CV to see how your skills and experience align with the role.Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEARequired SkillsPreferred Skills:Analytical Reasoning, Business Alignment,Sourced from LinkedIn. Relocantly aggregates public job postings; apply on the original site.