QC Labs Ops & LIMS Process Expert

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

About Lilly

At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly.

About Technology@Lilly

At Lilly, technology is not a support function. It is how a global medicine company operates, innovates, and delivers. Lilly in Hyderabad builds the capabilities that make this possible, cloud platforms, AI systems, and automation at enterprise scale, all in service of a purpose that makes this technology work genuinely distinctive, from advancing drug discovery to enabling connected clinical trials to keeping a global medicine company running at the standard patients deserve.

About the Business Function

The Global Manufacturing & Quality Labs - Lab Systems team delivers and sustains lab informatics platforms enabling GMP-compliant laboratory operations across Lilly's global manufacturing network. We build, implement, and support coordinated digital lab solutions that ensure data integrity, regulatory compliance, and efficient analytical and quality control processes.

Job Role: QC Labs Ops & LIMS Process Expert

Role Overview

This role is for Technology@Lilly Manufacturing & Quality and provides deep pharmaceutical Quality Control process expertise, including the scientific processes performed on laboratory equipment, to support the design, harmonization, implementation, and deployment of LabVantage and connected laboratory solutions across the manufacturing network. The role bridges laboratory users and technology delivery teams by translating scientific and quality processes into standardized LIMS workflows, master data, functional requirements, test scenarios, and sustainable global ways of working.

Key Responsibilities

QC Process Expertise & Harmonization

Serve as a 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.

LabVantage Implementation & Functional Design

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.

Laboratory Processes & Master Data

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.

Connected Laboratory Process Design

Define business-process and data requirements for connections between LabVantage and laboratory systems.

Provide process expertise for flows involving 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.

Testing, Validation & Deployment Readiness

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.

Governance, Data Integrity & Regulatory Compliance

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 Should Bring

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.

Basic Qualifications

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.

Preferred Experience

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.

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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