At Lilly we unite caring with discovery to make life better for people around the world We are a global healthcare leader headquartered in Indianapolis Indiana Our employees around the world work to discover and bring life-changing medicines to those who need them improve the understanding and management of disease and give back to our communities through philanthropy and volunteerism We give our best effort to our work and we put people first We re looking for people who are determined to make life better for people around the world About the Technology Organization Technology at Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose - creating medicines that make life better for people around the world like data driven drug discovery and connected clinical trials We hire the best technology professionals from a variety of backgrounds so they can bring an assortment of knowledge skills and diverse thinking to deliver innovative solutions in every area of the enterprise About the Business Function From molecule to market Global Manufacturing plays an important role in every step along a product s lifecycle Most of our customers never see the scientific and technical resources behind our medicines But customers experience every day the performance of our high-quality products and global supply network Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products Engineering Manufacturing Information Control Systems MI CS Technology Services Manufacturing Science Global Health Safety and Environment and Global Supply Chain Job Title Associate Director - Lab Methods Instrument Management LabVantage QC Labs The Associate Director will lead and manage our LabVantage LIMS Laboratory Information Management System technology initiatives within our pharmaceutical operations This role will oversee master data management and instrument management primarily The Associate Director will ensure that LabVantage technology supports high-quality compliant and efficient laboratory operations aligned with business objectives Key Responsibilities What you ll be doing LabVantage System Ownership for QC Operations Lead the design configuration and governance of LabVantage modules supporting QC testing Lab Methods and Instrument Management Ensure the LIMS supports regulatory and data integrity requirements GMP GxP 21 CFR Part 11 Annex 11 Oversee change control validation and release management of new functionalities and configurations Laboratory Methods Lifecycle Management Govern the creation approval and lifecycle maintenance of analytical test methods within LabVantage Ensure that method parameters specifications and versioning are accurately configured and linked to products and stability protocols Partner with global stakeholders analytical Development and QA to digitally standardize and harmonize test methods across manufacturing sites Drive method verification migration and archival processes during method transfers or updates Instrument Management Manage a team that will create the drivers for the instruments that will support lab methods and ensure connectivity to LV Ensure all instrument metadata and status are accurately reflected for real-time availability and compliance Collaborate with Engineering and IT to ensure instrument connectivity validation and audit-readiness Data Integrity Compliance Assurance Implement and enforce data governance frameworks within LabVantage for QC operations Ensure compliance with data integrity principles ALCOA audit trails and secure access controls Support internal and regulatory audits by ensuring traceable and compliant method and instrument records Drive periodic reviews and assessments to ensure system validation and GMP compliance remain current QC Process Optimization Digital Transformation Partner with global stakeholders QC and Manufacturing Quality teams to standardize workflows templates and test execution processes in LabVantage Identify and implement continuous improvement opportunities to simplify data entry and improve turnaround times Team Leadership Capability Development Lead and mentor a team of Lab method development engineers and instrument driver development engineers Build team expertise in method digitalization instrument integration and compliance management Promote a culture of quality ownership and continuous improvement within the QC digital systems team How you will succeed Enable Data-Driven Compliant QC Operations By ensuring LabVantage is robustly configured for method and instrument management the role will strengthen data integrity compliance and traceability across all QC processes Accelerate Digital Transformation and Efficiency Through automation system integration and standardized workflows it will reduce manual effort enhance turnaround times and drive paperless efficient lab operations Foster Global Alignment and Continuous Improvement By harmonizing QC LIMS practices across sites and developing a skilled informatics team the role will promote scalability quality culture and sustainable operational excellence What you should bring Deep LabVantage and QC Domain Expertise Proven experience in configuring validating and governing LabVantage modules for QC labs with a strong grasp of analytical methods instrument lifecycle and GMP workflows Solid Compliance and Data Integrity Mindset In-depth understanding of GxP 21 CFR Part 11 and ALCOA principles to ensure systems processes and data meet global regulatory expectations Digital Transformation and Integration Capability Ability to drive lab digitalization by integrating instruments automating data capture and enabling paperless standardized and globally scalable QC operations Leadership and Cross-Functional Influence Skilled in leading high-performing teams partnering with Quality IT and Manufacturing functions and aligning global stakeholders toward a unified LIMS strategy Basic Qualifications and Experience Requirement Bachelor s or Master s degree in Engineering Computer Science Information Systems or related field 12 years of overall experience in the IT Industry with at least 10 years in the pharma industry working with data and minimum 5 years of experience in leading a team At least 5-7 years of hands-on or leadership experience managing or configuring LabVantage LIMS within GxP-regulated QC environments Proven experience in method and instrument management including digitalization of test methods instrument qualification workflows and data lifecycle governance Exposure to regulatory compliance frameworks such as GMP GxP 21 CFR Part 11 and data integrity ALCOA principles Demonstrated track record in system validation CSV change control and audit readiness for laboratory informatics systems Additional Skills Preferences Knowledge of industrial IoT digital manufacturing and smart factory concepts Experience with data analytics platforms and reporting tools Strong strategic thinking and ability to align technology initiatives with business objectives Additional Information N A 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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📌 Assoc. Dir – Lab Methods & Instrument Management (labvantage, Qc Labs) (Telangana)
🏢 Eli Lilly
📍 Telangana