Subject Matter Expert (SME) - Laboratory Informatics & LIMS- Remote

Job Summary Subject Matter Expert (SME) – Laboratory Informatics & LIMS- Remote Experience: 10–15+ Years Role Summary Seeking an experienced Subject Matter Expert (SME) with 15+ years of experience in Life Sciences, Healthcare, Laboratory Informatics, and Clinical Research systems.

Key Responsibilities

• Serve as the primary SME for LIMS and associated laboratory workflows.
• Understand end-to-end clinical laboratory operations including sample lifecycle management, study management, test management, results processing, reporting, and data delivery.
• Gather, analyze, and document business requirements from laboratory stakeholders and clinical operations teams.
• Support onboarding of new laboratories, regions, studies, and customers.
• Collaborate with business stakeholders, laboratory teams, technology teams, vendors, and leadership to define and deliver business solutions.
• Analyze laboratory workflows and translate business requirements into scalable, compliant system solutions.
• Manage risks, dependencies, issues, and mitigation plans to ensure predictable delivery outcomes.
• Oversee data migration, system integration, release planning, change management, and deployment activities.
• Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, data integrity, and validation requirements.
• Support validation activities including URS, FRS, IQ/OQ/PQ, traceability, audit readiness, CAPA, and change control processes.
• Drive continuous improvement, process optimization, and adoption of industry best practices.

Required Skills & Experience

• 10+ years of experience delivering Life Sciences and Healthcare IT programs.
• Strong expertise in:
  • Laboratory Information Management Systems (LIMS).
  • Chromatography Data Systems (CDS).
  • Clinical Trial Management Systems (CTMS/TMS).
  • Laboratory Informatics Platforms.
  • Clinical and Laboratory Operations.
• Hands-on experience with system implementation, migration, upgrades, integrations, and support.
• Strong understanding of laboratory workflows, sample lifecycle management, study management, and data management.
• Experience with validation and compliance frameworks including GxP, GAMP 5, CSV/CSA, and 21 CFR Part 11.
• Knowledge of data migration, ETL processes, APIs, system integrations, and reporting solutions.
• Strong stakeholder management, business analysis, and consulting skills.
• Experience working in global delivery and regulated environments.

Preferred Qualifications

• Experience across pharmaceutical, biotechnology, CRO, diagnostics, or healthcare organizations.
• Exposure to cloud-based laboratory platforms, analytics, and AI-enabled solutions.
• PMP, CBAP, Agile/Scrum, or relevant Life Sciences certifications.
• Strong leadership, communication, presentation, and problem-solving skills.

Other Job Details

• Interviews: Video interviews.
• Docs required: ID proof will be required.
• Availability: Candidates able to join immediately are preferred.