Digital Quality Applications Manager (LIMS)
hace 3 días
Castro Urdiales
In a few words: Position: Digital Quality Applications Manager (LIMS) Location: Madrid (On site) Experience: Minimum 7 years’ experience managing and supporting LabWare LIMS in a global, multi-site environment. 🚀 Ready to lead the future of Quality? Insud Pharma is hiring a Digital Quality Applications Manager (LIMS)to drive our digital transformation journey across a truly global Quality organization. 🌍 About the role: Ready to be a #Challenger? The Global Labware LIMS Manager will be responsible for the strategic planning, implementation, maintenance, and optimization of the LabWare LIMS (Laboratory Information Management System) across all global laboratory operations. This role will serve as the primary expert for LabWare LIMS, ensuring its effective utilization to support laboratory workflows, data management, regulatory compliance (e.g., GLP, GMP), and business objectives. The role will possess a deep understanding of laboratory processes, IT systems, and project management, with a proven track record of successfully managing complex LIMS initiatives in a global environment. Digital Quality Applications Manager (LIMS) is responsible for: Strategic Leadership & Roadmap: • Develop and execute a global LabWare LIMS strategy and roadmap that aligns with business goals, laboratory needs, and IT architecture. Identify opportunities for LIMS enhancements and new functionalities. System Management & Support: • Oversee the day-to-day operations, configuration, and administration of the LabWare LIMS system., • Provide expert-level support, troubleshooting, and resolution for LIMS-related issues., • Manage user accounts, roles, and permissions to ensure data security and integrity., • Coordinate with IT infrastructure teams for system upgrades, patches, and performance optimization. Implementation & Deployment: • Lead and manage new LabWare LIMS implementations, expansions, and module deployments across various global sites. This includes requirements gathering, system design, configuration, testing, validation, and go-live activities. Data Management & Integration: • Ensure the integrity, accuracy, and accessibility of laboratory data within LIMS., • Oversee data migration activities and develop strategies for data archiving and retention., • Manage integration points between LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS) to ensure seamless data flow. User Training & Adoption: • Develop and deliver comprehensive training programs for LIMS users at all levels. Promote best practices and ensure optimal system adoption across global laboratories. Compliance & Validation: • Ensure LabWare LIMS adherence to relevant regulatory requirements (e.g., FDA 21 CFR Part 11, GxP)., • Oversee and participate in system validation activities, including developing validation plans, executing protocols (IQ, OQ, PQ), and generating validation reports., • Maintain detailed documentation for all LIMS configurations, changes, and validations. Project & Vendor Management: • Manage LIMS-related projects from conception to completion, including scope definition, resource allocation, timeline management, and budget tracking., • Act as the primary liaison with LabWare and other third-party vendors for support, new features, and professional services. Continuous Improvement: • Proactively identify areas for LIMS process improvement, automation, and efficiency gains. Implement enhancements to optimize laboratory workflows and data management. Team Leadership: • Recruit, mentor, and develop a team of LIMS team. Foster a collaborative and high-performing team environment. What do you need? • Education: Bachelor's degree in Computer Science, Information Technology, Chemistry, Biology, or a related scientific/engineering field. Master's degree preferred., • Languages: Fluent Spanish, English, knowledge of other languages will be an asset., • Experience (years/area): Minimum of 7-10 years of experience managing and supporting LabWare LIMS in a global, multi-site environment., • Specific Knowledge: Proven experience with multiple full lifecycle LabWare LIMS implementations or major upgrade projects. Strong understanding of laboratory operations, workflows, and data management in analytical, QC, R&D, or manufacturing environments. Experience working in a regulated industry (e.g., Pharmaceutical, Biotech, Medical Device, Chemical) with a strong understanding of GxP, ISO 17025, and 21 CFR Part 11 regulations. Experience with system validation (IQ, OQ, PQ) in a regulated environment.In-depth expertise in LabWare LIMS configuration, master data management, instrument interfacing, and reporting.Proficiency in LabWare LIMS scripting (e.g., LIMS Basic).Strong SQL skills (e.g., Oracle, SQL Server) for data querying and analysis.Experience with LIMS integration technologies (e.g., web services, APIs, middleware).Familiarity with other laboratory informatics systems (e.g., ELN, CDS, SDMS) is a plus., • Travels: about 20% of the time, though this percentage may be increased., • Personal skills: Strong project management skills with the ability to manage multiple priorities simultaneously.Strong analytical and problem-solving abilities.Exceptional communication, interpersonal, and presentation skills with the ability to interact effectively with all levels of the organization and external stakeholders.Ability to work independently and collaboratively in a global team environment.Strong attention to detail and commitment to quality., • Preferred Qualifications: Project Management (PMP)training. Experience introducing emerging technologies (AI, data analytics) in the Quality space. Familiarity with agile working methodologies and digital transformation frameworks. 👩💻👨💻 Why Join Us? • Play a critical role in shaping the future of Quality at a leading global pharmaceutical company., • Lead cutting-edge digital initiatives that impact healthcare worldwide., • Work with diverse, passionate teams across continents., • Access outstanding opportunities for growth and professional development., • Make a real impact on patient lives around the globe. ✨ Join us at Insud Pharma and be part of a company where innovation, purpose, and excellence drive everything we do. Let’s shape the future of healthcare together. What will the Selection process be like? ➡Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels. ➡Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test. ➡Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process. COMMITMENT TO EQUAL OPPORTUNITIES Insud Pharma is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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