Senior Digital Quality Lead (CSQA)

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

Job summary

Lilly seeks a Digital Quality Expert for Catalyze360 to define the digital quality strategy and embed risk-based assurance and CSA practices into agile software delivery across internal and external systems and platforms.

The role requires cross-organizational collaboration to ensure submission-ready, audit-ready execution and to guide stakeholders in quality requirements, design controls, and risk management across the product lifecycle.

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, including interpreting CSV standards and external regulations and translating them into practical quality requirements.
• Own the digital quality strategy across the portfolio; lead design and implementation of the quality management system (QMS), design controls, and risk-management artifacts required to release, iterate, and monitor digital systems and tools.
• Perform ongoing product and system risk assessments to identify compliance and performance gaps; recommend and drive corrective actions across engineering and product teams.
• Manage deviations, change control (including AI/ML model change management), incident and issue management, root-cause investigations, and CAPAs for products and systems through documented resolution; serve as BQA/CSQA for critical internal business systems, including review and approval of related IT system documentation.
• Lead readiness efforts across internal and external audits.
• Coordinate internal stakeholders and third parties to resolve complex issues and prevent recurrence.
• Deliver key quality data—compliance, conformance, model performance, cybersecurity posture, risks, and issues—to inform stakeholder decisions, and drive quality improvement and best-practice harmonization across internal teams and partner engagements.
• Evaluate software development lifecycle, QMS maturity, and AI/ML governance.
• Mobilize cross-functional teams across Lilly and third parties, applying product and agile delivery discipline to embed quality into CI/CD pipelines and build simple, workable solutions.
• Act as Catalyze360 Quality’s principal digital quality point of contact for external engagements; set expectations and build trusted internal and external relationships across product, engineering, and subject matter experts.

Skills

Software quality

CSV/CSA

Regulatory compliance

AI/ML governance

Quality management system

Risk assessment

Audits

CI/CD

Information security

Communication

Education

Bachelor’s degree in a technology-related field

Tools

CSQA

GxP/CSV frameworks

Job description

Lilly seeks a Digital Quality Expert for Catalyze360 to define the digital quality strategy and embed risk-based assurance and CSA practices into agile software delivery across internal and external systems and platforms.

The role requires cross-organizational collaboration to ensure submission-ready, audit-ready execution and to guide stakeholders in quality requirements, design controls, and risk management across the product lifecycle.