Associate Director – Lab Methods & Instrument Management (LabVantage, QC Labs)
Location: Hyderabad, Telangana, India
Category: Information Technology / Quality Control
Job Type: Full-Time, Regular
Job ID: R-96173
Experience Required: 12+ years (including 10+ years in pharma IT and 5+ years in team leadership; 5–7 years LabVantage LIMS experience)
About the Company
Lilly is a global healthcare leader committed to improving lives through scientific innovation, advanced technology, and high-quality medicines. Headquartered in Indianapolis, the company operates with a strong culture of integrity, people-first values, and continuous improvement across global research, manufacturing, and commercial operations.
About the Technology Organization
Technology at Lilly drives digital innovation using advanced tools, data-driven capabilities, and connected systems that support drug discovery, clinical development, manufacturing excellence, and global supply chain operations. The team leverages modern enterprise technologies to support compliant, efficient, and scalable operations across all business functions.
About the Global Manufacturing Function
Global Manufacturing oversees all processes from molecule to market, ensuring consistent delivery of high-quality medicines. Core functions include Engineering, Manufacturing Information & Control Systems (MI&CS), Manufacturing Science, Global Supply Chain, and Global Health, Safety, and Environment.
Role Overview
The Associate Director – Lab Methods & Instrument Management (LabVantage, QC Labs) will lead LabVantage LIMS strategy, configuration, and governance for Quality Control operations. This role focuses on digitalizing analytical method management, overseeing instrument connectivity and lifecycle data, ensuring regulatory compliance, and strengthening QC systems through standardization and automation.
Key Responsibilities
1. LabVantage LIMS Ownership for QC Operations
Lead design, configuration, and oversight of LabVantage modules related to QC testing, lab methods, and instrument management.
Ensure full compliance with GMP, GxP, 21 CFR Part 11, Annex 11, and global data integrity standards.
Oversee change management, system validation (CSV), release processes, and documentation.
2. Laboratory Methods Lifecycle Management
Govern creation, updates, approval workflows, and version control for analytical test methods within LabVantage.
Ensure method specifications, parameters, and stability links are accurately configured and traceable.
Drive method digitalization, harmonization, and global standardization across manufacturing sites.
3. Instrument Integration and Lifecycle Governance
Lead the development of instrument drivers and connectivity solutions supporting analytical methods.
Ensure accurate instrument metadata, qualification status, and availability within LIMS.
Partner with Engineering and IT teams to maintain audit-ready, validated instrument systems.
4. Data Integrity and Compliance
Establish and enforce data governance and ALCOA+ principles within QC LIMS operations.
Maintain secure access, audit trails, and traceability for all method and instrument records.
Support internal and external audits through validated, compliant digital workflows.
5. QC Workflow Optimization and Digital Transformation
Partner with QC and Manufacturing Quality teams to standardize digital workflows, templates, and execution processes.
Identify opportunities to reduce manual effort, streamline test execution, and drive paperless QC labs.
Implement automation and system integration initiatives to improve cycle times and operational efficiency.
6. Team Leadership & Capability Building
Lead a team of method digitization specialists and instrument driver engineers.
Develop expertise in LabVantage configuration, instrument connectivity, and compliance management.
Foster a culture of ownership, improvement, quality, and digital innovation.
Success Indicators
A robustly configured and compliant LabVantage LIMS supporting all QC operations.
Improved data integrity, traceability, and audit readiness across laboratory workflows.
Accelerated method execution and reduced turnaround times through digital standardization.
Strong global alignment in LIMS practices and well-trained informatics teams.
Efficient, paperless, integrated QC operations supporting manufacturing performance.
Candidate Requirements
Basic Qualifications
Bachelor’s or Master’s degree in Engineering, Computer Science, Information Systems, or related field.
Minimum 12+ years of IT experience, including 10+ years in the pharmaceutical industry.
At least 5+ years of team leadership experience.
5–7 years of hands-on or leadership experience with LabVantage LIMS in GxP-regulated QC environments.
Expertise in analytical method digitalization, instrument lifecycle governance, and QC workflows.
Sound understanding of GMP, GxP, 21 CFR Part 11, and ALCOA+ principles.
Proven experience in change control, CSV, and audit readiness.
Preferred Skills
Knowledge of industrial IoT, smart manufacturing, and digital lab technologies.
Familiarity with data analytics platforms and reporting tools.
Strong strategic thinking and the ability to align digital initiatives with organizational goals.
Equal Opportunity Statement
Lilly is committed to providing equal employment opportunities and ensuring accessibility for individuals with disabilities. No applicant will be discriminated against based on race, religion, gender, orientation, national origin, veteran status, disability, or any legally protected category.
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