Associate Director – Lab Systems

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 Systems & Data (QC Labs)

 
The Associate Director will lead and manage our LabVantage LIMS (Laboratory Information Management System) technology initiatives within our pharmaceutical operations.  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/ Lab systems Support

o   Provide strategic and operational leadership for LabVantage LIMS configuration and lifecycle management, ensuring alignment with business processes and regulatory standards working with global stakeholders.

o   Oversee Empower CDS, SmartLab ELN, and Darwin (or equivalent data platforms), ensuring seamless interoperability and compliant data flow across systems.

o   Define and manage the digital lab ecosystem roadmap, ensuring systems are integrated, scalable, and support global harmonization.

·       System Configuration, Enhancement & Governance

o   Lead a team responsible for configuring, validating, and maintaining LabVantage modules, including sample management, methods, instruments, and stability.

o   Establish strong system governance frameworks, including change control, release management, and documentation aligned to GxP and Part 11 requirements.

o   Partner with IT, QA, and business stakeholders to prioritize enhancements and manage vendor relationships effectively.

·       Data Management & Analytics Enablement

o   Drive data integrity, accuracy, and standardization across laboratory and manufacturing data systems.

o   Enable centralized data analytics and visualization using LabVantage, Darwin, or connected data lakes to support QC and manufacturing insights.

o   Ensure data traceability and interoperability between LIMS, CDS, ELN, and ERP/MES systems for end-to-end digital continuity.

·       Digital Transformation & Continuous Improvement

o   Champion digital lab initiatives, including paperless workflows, method automation, and instrument integration to improve efficiency and compliance.

o   Identify and implement process optimization opportunities through data-driven insights, automation, and AI/ML-ready data foundations.

o   Collaborate with global and site stakeholders to standardize processes and enable consistent, high-quality system usage.

·       Compliance & Audit Readiness

o   Ensure all systems operate in compliance with GxP, 21 CFR Part 11, Annex 11, and data integrity guidelines.

o   Maintain validated states of all systems through periodic reviews, assessments, and revalidations.

o   Support internal and external audits by ensuring system documentation, access controls, and data trails meet regulatory expectations.

·       Leadership & Capability Development

o   Build and lead a high-performing team of LIMS administrators, business analysts, data engineers, and validation specialists.

o   Develop internal capability in lab informatics, data integration, and analytics to reduce dependency on external vendors.

o   Foster a culture of innovation, compliance, and collaboration, empowering the team to deliver sustainable, value-driven digital solutions

How you will succeed: 

·       Deliver an Integrated, Compliant Digital Lab Ecosystem: By harmonizing LabVantage, Empower, SmartLab, and Darwin systems to enable seamless data flow, standardized workflows, and regulatory compliance across all QC and manufacturing sites.

·       Transform Data into Actionable Insights: Through strong data governance and analytics enablement, turning laboratory and manufacturing data into intelligence that drives faster, more informed decision-making.

·       Build High-Performing, Future-Ready Teams and Processes: By developing a skilled informatics team, fostering cross-functional collaboration, and driving continuous improvement to sustain long-term digital transformation and 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 Life Sciences, Pharma, Engineering, Computer Science, Information Systems, or related field. 

· 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.  

·      Exposure to MuleSoft or similar integration platforms. 

·      Strong understanding of manufacturing operations, MES, ERP, and LIMS systems. 

·      Proven experience in leading cross-functional technology teams and driving complex projects. 

·      Excellent problem-solving, communication, and stakeholder management skills. 

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 ) 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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