Senior Digital Quality Lead (Regulated Software & AI/ML)

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Job summary

Lilly is seeking a Digital Quality Expert for Catalyze360 in Indianapolis. You will set the digital quality strategy, embed CSA practices into agile software delivery, and guide stakeholders to deliver audit-ready, submission-ready results across internal and external systems.

You will own design controls, risk management artifacts, and readiness for internal/external audits, coordinating across product, engineering, and third parties while ensuring quality across CI/CD pipelines and AI/ML

Qualifications

• Bachelor's degree in a technology-related field (e.g., Computer Science, Software Engineering, Biomedical Engineering, Information Systems).
• 6+ years of relevant industry experience in software quality for digital systems and tools or in Computer System Validation with meaningful exposure to software.

Responsibilities

• Serve as software quality subject-matter expert for internal and external systems and tools; translate CSV/CSA requirements into quality requirements.
• Own the digital quality strategy across the portfolio; design and implement the quality management system (QMS) and risk-management artifacts for release, iterate, and monitor digital systems.
• Perform ongoing risk assessments to identify compliance gaps; drive corrective actions with engineering and product teams.
• Lead change control, incident management, root-cause investigations and CAPAs; serve as BQA/CSQA for key internal systems; review related IT documentation.
• Lead readiness efforts across internal and external audits; coordinate stakeholders and third parties to resolve complex issues.
• Deliver key quality data (compliance, model performance, cybersecurity posture) to inform decisions and drive harmonization.
• Evaluate software development lifecycle, QMS maturity, and AI/ML governance; embed quality into CI/CD pipelines.
• Mobilize cross-functional teams applying agile delivery discipline to build simple, workable quality solutions.

Skills

Software quality

CSV/CSA

IT regulations

AI/ML governance

Information Security

Programming

Data Analytics

Cloud

Microsoft Office

English proficiency

Education

Bachelor's degree in a technology-related field

Tools

QMS software

Job description

Lilly is seeking a Digital Quality Expert for Catalyze360 in Indianapolis. You will set the digital quality strategy, embed CSA practices into agile software delivery, and guide stakeholders to deliver audit-ready, submission-ready results across internal and external systems.

You will own design controls, risk management artifacts, and readiness for internal/external audits, coordinating across product, engineering, and third parties while ensuring quality across CI/CD pipelines and AI/ML