Delivery Director - LIMS
21 hours ago
Valencia
Who we are: Born digital, UST transforms lives through the power of technology. We walk alongside our clients and partners, embedding innovation and agility into everything they do. We help them create transformative experiences and human-centered solutions for a better world. UST is a mission-driven group of over 30,000+ practical problem solvers and creative thinkers in over 30+ countries. Our entrepreneurial teams are empowered to innovate, act nimbly, and create a lasting and sustainable impact for our clients, their customers, and the communities in which we live. With us, you’ll create a boundless impact that transforms your career—and the lives of people across the world. Visit us at ___. You Are: Director, Lab Informatics Department: IT CoE Reports To: IT CoE Sr. Director The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory compliance. The incumbent will serve as the principal liaison between laboratory stakeholders, IT, QA, and regulatory affairs to deliver robust, scalable, and compliant digital solutions. The Opportunity: Strategic Leadership & Planning • Develop and lead the execution of a multi-year lab informatics roadmap aligned with corporate digital transformation goals., • Conduct market and internal needs assessments to identify technology gaps and opportunities for automation and integration., • Provide vision and strategic direction for the adoption of cloud-based and AI-driven technologies., • Influence senior leadership decisions by providing insight into informatics trends and capabilities. Project Oversight & System Ownership • Lead end-to-end lifecycle management of key lab systems including ELN (Electronic Lab Notebook), LIMS (Laboratory Information Management System), CDS (Chromatography Data System), and SDMS (Scientific Data Management System)., • Drive cross-functional project teams through software selection, system design, implementation, validation, and deployment., • Maintain ownership of system governance, change management, and version control processes., • Ensure timely resolution of system issues and continuous improvement through user feedback and performance metrics. Operations & Compliance • Ensure informatics systems are compliant with global regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)., • Collaborate with QA and Compliance teams to perform risk assessments and periodic reviews of computerized systems., • Lead preparation and support during regulatory inspections and internal audits., • Establish robust procedures for electronic data management, archival, and retrieval. Team Leadership • Recruit, develop, and manage a multidisciplinary team of informatics professionals, system administrators, and project managers., • Foster a culture of collaboration, accountability, and innovation., • Provide coaching, mentoring, and performance management to support professional growth and knowledge sharing. Cross-functional Collaboration • Act as the primary interface between scientific end-users, IT infrastructure teams, software vendors, and senior management., • Translate complex scientific and operational requirements into technical specifications and implementation plans., • Drive user adoption and change management initiatives through effective communication and training programs. Design and facilitate the transition plan of technology responsibilities build the accelerated adoption strategy for LIMS 12.2 • Provide leadership support of the LIMS 21.3 upgrade, • Provide hands on execution/leadership for the deployment of the LIMS/SAP interface, • Accelerate legacy LIMS decomm strategy, • Support ELN roadmap for 2026 and 2027, • Help drive final decision with Empower/Chromeleon Support solution decision and strategic plan for EM rollout (global) What you need: Education & Experience • Bachelor’s degree in Life Sciences, Computer Science, Bioinformatics, or a related field is required; advanced degree (MS, PhD, or MBA) preferred., • Minimum of 10 years of progressive experience in lab informatics, with at least 5 years in a leadership role within a pharmaceutical, biotech, or CDMO environment., • Proven track record in leading successful implementations of laboratory software systems in GxP-regulated environments. Skills & Knowledge • Deep understanding of laboratory workflows, sample lifecycle management, and analytical instrumentation., • Expertise in system validation, data integrity principles, and GxP compliance., • Strong project management skills with experience using Agile and Waterfall methodologies., • Excellent interpersonal, organizational, and communication skills, with the ability to influence at all levels of the organization. Preferred: • Experience managing lab informatics systems across multiple global manufacturing or R&D sites., • Familiarity with integration of lab systems with enterprise platforms such as ERP (SAP), MES, and QMS., • Understanding of emerging technologies including AI/ML, NLP, and data visualization tools., • Certifications in project management (e.g., PMP) or systems validation (e.g., GAMP) are a plus. What we believe: We’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion, and to place people at the center of everything we do. Humility: We will listen, learn, be empathetic and help selflessly in our interactions with everyone. Humanity: Through business, we will better the lives of those less fortunate than ourselves. Integrity: We honor our commitments and act with responsibility in all our relationships. Equal Employment Opportunity Statement UST is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.