Digital Quality Lead: CSQA, AI/ML & Compliance

Regulatory Jobs; United States; Hybrid; USD 129,000 - 211,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Medical, dental, vision coverage

Well-being programs

Job summary

Lilly Catalyze360 is seeking a Digital Quality Expert to lead the digital quality strategy across internal and external systems. You will embed risk-based assurance, CSA practices, and readiness for audits within agile software delivery, guiding cross-organizational stakeholders to submission-ready, audit-ready execution.

The role requires CSQA or equivalent, 6+ years in software quality, and strong knowledge of IT controls, data privacy, and AI/ML governance. Travel up to 10% is possible.

Qualifications

• Bachelor's degree in a technology-related field (e.g., CS, SWE, BME, IS).
• 6+ years in software quality for digital systems or CSV/CSA.
• CSQA certification or equivalent qualification preferred.

Responsibilities

• Serve as software quality expert for internal and external systems.
• Own digital quality strategy; implement QMS and risk artifacts.
• Conduct risk assessments; drive corrective actions with teams.
• Manage deviations, change control, incidents, CAPAs.
• Lead readiness for internal and external audits.
• Collaborate with stakeholders to ensure audit-ready submissions.
• Monitor model governance and cybersecurity posture.
• Embed quality into CI/CD pipelines and agile delivery.

Skills

Quality governance

AI/ML governance

Regulated software

Cross-functional

Risk management

Cybersecurity

CI/CD quality

Education

Bachelor's degree in a technology-related field

CSQA Certification

Tools

CSQA Certification

ITIL

Six Sigma

Job description

Lilly Catalyze360 is seeking a Digital Quality Expert to lead the digital quality strategy across internal and external systems. You will embed risk-based assurance, CSA practices, and readiness for audits within agile software delivery, guiding cross-organizational stakeholders to submission-ready, audit-ready execution.

The role requires CSQA or equivalent, 6+ years in software quality, and strong knowledge of IT controls, data privacy, and AI/ML governance. Travel up to 10% is possible.