Senior Data Modeler

• The Director of Laboratory Informatics will provide strategic leadership and technical direction for the development, implementation, and optimization of laboratory information systems across global sites.
• This role will drive digital transformation, ensuring system integration, regulatory compliance, and innovation in support of scientific and operational excellence.

Strategic Leadership And Planning:

• Develop and execute a multi-year lab informatics roadmap aligned with corporate digital transformation objectives.
• Conduct market and internal needs assessments to identify technology gaps and opportunities for automation and integration.
• Provide strategic direction for adopting cloud-based and AI-driven technologies.
• Influence senior leadership by offering insights into informatics trends and technological advancements.

• Lead end-to-end lifecycle management of core lab systems including ELN, LIMS, CDS, and SDMS.
• Direct cross-functional teams through software selection, system design, implementation, validation, and deployment.
• Oversee governance, change management, and version control for all lab informatics systems.
• Drive continuous improvement through performance metrics and user feedback.

• Ensure all informatics systems comply with regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
• Collaborate with QA and Compliance teams to perform system risk assessments and reviews.
• Support and prepare for regulatory inspections and internal audits.
• Establish robust data management, archival, and retrieval procedures.

• Recruit, develop, and lead a multidisciplinary team of informatics experts, administrators, and project managers.
• Foster a culture of accountability, innovation, and collaboration.
• Provide mentoring and professional development opportunities to team members.

• Serve as the primary liaison among scientific users, IT teams, vendors, and senior management.
• Translate scientific and operational needs into technical specifications and implementation plans.
• Lead user adoption initiatives and deliver effective training and communication programs.

• Design and facilitate the transition plan of technology responsibilities.
• Build the accelerated adoption strategy for LIMS 12.2.
• Lead the LIMS 21.3 upgrade initiative.
• Provide hands-on leadership for the deployment of the LIMS/SAP interface.
• Accelerate the decommissioning strategy for legacy LIMS systems.
• Support the ELN roadmap for 2026 and 2027.
• Drive decision-making for Empower/Chromeleon solutions.
• Support strategic planning and rollout of the EM global solution.

• Bachelor s degree in Life Sciences, Computer Science, Bioinformatics, or a related field required.
• Advanced degree (MS, PhD, or MBA) preferred.
• Minimum 10 years of progressive lab informatics experience, including at least 5 years in a leadership role within pharmaceutical, biotech, or CDMO environments.
• Proven track record in implementing laboratory software systems within GxP-regulated settings.

• Strong understanding of laboratory workflows, sample management, and analytical instrumentation.
• Expertise in system validation, data integrity, and GxP compliance.
• Solid project management experience using Agile and Waterfall methodologies.
• Excellent communication, leadership, and stakeholder management skills.

• Experience managing global lab informatics systems across manufacturing or R&D sites.
• Knowledge of integrating lab systems with enterprise platforms such as ERP (SAP), MES, and QMS.
• Familiarity with AI/ML, NLP, and data visualization technologies.
• Certifications in Project Management (PMP) or System Validation (GAMP) are advantageous.