Digital Quality Lead for Regulated Software (CSQA)

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

Benefits offered by this job

Company bonus

401(k) plan

Pension

Medical, dental, vision benefits

Flexible benefits

Life insurance

Job summary

Lilly Catalyze360 seeks an experienced digital quality expert to drive the quality strategy across internal and external platforms. You will embed risk-based assurance and CSA practices into agile software delivery, and guide stakeholders to submission-ready, audit-ready execution.

In this role, you will design and implement a comprehensive QMS, lead design controls, manage deviations and CAPAs, and coordinate readiness for internal and external audits while partnering with product, engineering,

Qualifications

• Bachelor's degree in a technology-related field.
• 6+ years of experience in software quality for digital systems or CSV/CSA.
• CSQA qualification program upon hire or equivalent.

Responsibilities

• Serve as software quality SME for internal/external systems and tools; translate CSV standards into quality requirements.
• Own digital quality strategy; design/implement the QMS, design controls, and risk artifacts for release and monitoring.
• Perform risk assessments; drive corrective actions across engineering and product teams.
• Manage deviations, change control, incident/issue management, root-cause investigations, and CAPAs.
• Lead readiness for internal and external audits; coordinate with partners to resolve issues.

Skills

Quality management

CSV/CSA

AI/ML governance

Risk assessment

IT controls

Data privacy

Education

Bachelor's degree in CS/Engineering

Tools

QMS software

AI model governance tooling

Job description

Lilly Catalyze360 seeks an experienced digital quality expert to drive the quality strategy across internal and external platforms. You will embed risk-based assurance and CSA practices into agile software delivery, and guide stakeholders to submission-ready, audit-ready execution.

In this role, you will design and implement a comprehensive QMS, lead design controls, manage deviations and CAPAs, and coordinate readiness for internal and external audits while partnering with product, engineering,