QC Labs Ops & LIMS Process Expert

Overview

Provide deep pharmaceutical QC laboratory-process expertise to support the design, harmonization, implementation, and deployment of LabVantage and connected laboratory solutions across Lilly's manufacturing network.

What you'll do

• Serve as subject-matter expert for end-to-end pharmaceutical QC laboratory processes and LIMS-enabled workflows.
• Lead process mapping, fit-gap assessment, harmonization, and standardization across sites; identify justified local or regulatory variations.
• Promote MQ Labs standards, reusable process patterns, and best practices while challenging unnecessary customization.
• Facilitate global workshops with QC scientists, laboratory SMEs, Quality, product owners, and implementation partners to drive process decisions and adoption.
• Participate across LabVantage requirements, design, configuration review, demonstrations, testing, validation, deployment readiness, and post-deployment stabilization.
• Translate QC laboratory needs into clear functional requirements, process flows, user stories, acceptance criteria, and intended-use scenarios.
• Review proposed configurations and workflows for scientific fit, usability, compliance, standardization, and alignment with approved global processes.
• Support fit-gap decisions, functional issue resolution, defect triage, and business acceptance throughout the implementation lifecycle.
• Provide process expertise across sample receipt and lifecycle, specifications, analytical methods, tests, parameters, limits, result entry and review, approval, and release-support workflows.
• Define and harmonize requirements for stability programs, sterility testing, environmental monitoring, exceptions, investigations, retesting or resampling, and related QC workflows.
• Apply practical understanding of laboratory equipment processes, analytical data generation, review controls, instrument outputs, and relevant ICH expectations.
• Partner on laboratory master-data design, governance, creation, migration, verification, and lifecycle maintenance to ensure accuracy, consistency, traceability, and reuse.
• Ensure master-data structures and workflows reflect approved laboratory processes and support efficient global deployment.
• Define business-process and data requirements for connections between LabVantage and laboratory systems, including Empower/CDS, MODA-EM, ELN/LES, MES, SAP, and connected analytical instruments.
• Define business ownership, source and target data expectations, exception-handling scenarios, reconciliation needs, and user workflows for integrations.
• Identify opportunities to reduce manual transcription, simplify handoffs, and enable straight-through laboratory data flows.
• Partner with technical integration and platform teams while remaining focused on process, data, and functional requirements rather than infrastructure or driver engineering.
• Develop and review business-process test scenarios and acceptance criteria; support functional testing, UAT, validation, and defect triage.
• Partner with Quality and validation/CSQA teams to ensure intended use, requirements, testing, traceability, and process controls are appropriately addressed.
• Support site readiness, SOP and process alignment, training content, cutover planning, adoption, and hypercare from a QC-process perspective.
• Ensure deployed workflows remain aligned with approved global processes and drive feedback into continuous improvement and future releases.
• Apply GxP, data integrity, ALCOA+, 21 CFR Part 11, EU Annex 11, applicable ICH expectations, and risk-based CSV/CSA principles to LIMS process design and use.
• Ensure process requirements address appropriate review, approval, audit trail, electronic-record, traceability, and exception-management expectations.
• Support inspection readiness and provide QC/LIMS process expertise during USFDA, EMA/EMEA, and other regulatory inspections and audits.
• Partner with Quality to assess process impacts, address observations, and drive sustainable remediation where required.

What you'll need

• Bachelor's or Master's degree in Analytical Chemistry, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Life Sciences, Engineering, or a related discipline with relevant 6-12 years of experience.
• Significant experience in pharmaceutical or biotechnology QC laboratories, laboratory systems, LIMS implementation, or laboratory digital transformation.
• Demonstrated experience translating laboratory processes into LIMS requirements, workflows, master data, test scenarios, or configurations.
• Experience working across QC, Quality, Technology, validation, and implementation-partner teams.
• Deep pharmaceutical or biotechnology QC laboratory-process expertise.
• Hands-on understanding of LIMS-enabled laboratory workflows and experience participating in LabVantage or a comparable enterprise LIMS implementation.
• Strong experience with process harmonization, fit-gap analysis, functional requirements, laboratory master data, testing/UAT, validation, and deployment readiness.
• Practical knowledge of stability, sterility, environmental monitoring, sample management, analytical testing, specifications, results review, investigations, and release-support processes.
• Understanding of the scientific processes performed on common QC laboratory equipment and how results, metadata, controls, and exceptions are managed.
• Understanding of business and data flows involving Empower/CDS, MODA-EM, MES, SAP, ELN/LES, instruments, or related laboratory applications.
• Strong facilitation, stakeholder management, global collaboration, problem-solving, and change-adoption skills.
• Strong understanding of GxP, data integrity, CSV/CSA, ICH expectations, and regulatory inspection expectations for laboratory computerized systems.

Nice to have

• LabVantage implementation, harmonization, deployment, or process-design experience.
• Multi-site or global QC process standardization and laboratory master-data harmonization.
• Experience with Empower/CDS, MODA-EM, MES, SAP, stability, sterility, or environmental-monitoring workflows.
• Experience supporting USFDA, EMA/EMEA, or comparable inspections involving QC processes or laboratory computerized systems.

Details

• Location: Hyderabad, India.