Assoc. Dir – Lab Methods

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.
• Strong 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

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