Director – Manufacturing & Quality – Labs and TSMS at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Experience in strategic and operational leadership for digital and technology solutions in manufacturing and quality
Ability to work with global stakeholders to define and execute digital technology roadmaps aligned with business strategy
Expertise in lifecycle management of Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and related analytics platforms
Knowledge of data integrity, system validation, and compliance with GxP, 21 CFR Part 11, and global regulatory standards
Capability to lead cross-functional teams of IT professionals, business analysts, and solution architects
Understanding of advanced technologies including process digitalization, automation, ELN, AI/ML for predictive quality, process monitoring, process modelling, CPV, digital twins, and advanced analytics

Responsibilities

Work with global stakeholders to define and execute the digital technology roadmap for Quality Labs and TSMS in alignment with global manufacturing and quality strategy
Partner with business leaders to identify opportunities for process digitalization, automation, and data-driven decision-making
Lead a cross-functional team of IT professionals, business analysts, and solution architects delivering integrated, compliant solutions
Oversee lifecycle management of Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and related analytics platforms
Ensure delivery of nextgen Labs – LabVantage to all sites including Master Data Management, Configuration, Integrations and Data
Ensure data integrity, system validation, and compliance with GxP, 21 CFR Part 11, and global regulatory standards
Drive adoption of next-generation lab digitalization tools (e.g., ELN, AI/ML for predictive quality)
Partner with TSMS to enable process monitoring, process modelling CPV (Continued Process Verification), and digital twins
Provide digital tools to support process robustness, tech transfers, and investigation management
Champion advanced analytics and AI/ML models to predict and prevent manufacturing deviations
Maintain IT governance and change control processes across GxP systems
Ensure business continuity, cybersecurity compliance, and supplier oversight for all technology platforms
Lead risk assessments and audits to ensure system readiness and regulatory compliance

Skills

Key technologies and capabilities for this role

ManufacturingQuality ManagementDigital SolutionsTechnology LeadershipLabs ManagementTSMSEngineeringMI&CSGlobal Supply ChainData Driven Drug Discovery

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What are the key responsibilities for this role?

The role involves providing strategic and operational leadership for digital and technology solutions supporting Quality Laboratories and TSMS, including technology strategy, leadership, and oversight of systems like LIMS and CDS.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, putting people first, hiring diverse talent for innovative solutions, and focusing on advancing medicines through technology.

What makes a strong candidate for this Director role?

Strong candidates will have experience in strategic leadership, partnering with global stakeholders on technology roadmaps, leading cross-functional IT teams, and managing lifecycle of systems like LIMS and CDS in manufacturing and quality contexts.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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