Director, Lab Informatics

hace 3 semanas


Guadalajara, México Ust Global A tiempo completo

- 1 Opening- Guadalajara**Role description**:- **Director, Lab Informatics**- **Director I - Delivery Management**- **- **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 29,000+ practical problem solvers and creative thinkers in more than 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.** You Are**:- 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**:- 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.-- 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.-- 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.-- 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.-- 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 **** and ****-- Help drive final decision with Empower/Chromeleon-- Support solution decision and strategic plan for EM rollout (global)-- This position description identifies the responsibilities and tasks typically associated with the performance of the position.Other relevant essential functions may be required.** What you need**:- 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.-- 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


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