Senior Digital Quality Lead – Regulated Software & AI

Eli Lilly and Company; États-Unis; À distance; USD 129 000 - 211 000; Plein temps

Avantages offerts par ce poste

Company bonus

Comprehensive benefits

401(k) plan

Résumé du poste

Eli Lilly and Company, via Catalyze360, seeks a digital quality expert to own the quality strategy for internal and external systems. You will embed risk-based assurance and CSA practices into agile software delivery, guiding stakeholders toward submission-ready, audit-ready execution.

Lead readiness for audits, manage deviations and CAPAs, and drive QMS maturity, AI/ML governance, and cybersecurity posture across cross-functional teams to ensure compliant, scalable digital solutions.

Qualifications

• Bachelor's degree required.
• 6+ years in software quality for digital systems or CSV/CSA.
• Experience embedding quality into agile development and audits.

Responsabilités

• Serve as software quality SME for internal and external systems and tools; interpret CSV standards and regulations.
• Own the digital quality strategy; design and implement the QMS, design controls, and risk artifacts for releases.
• Conduct risk assessments to identify gaps; drive corrective actions with engineering and product teams.
• Manage deviations, change control, incident handling, root-cause investigations, and CAPAs; review IT system documentation.
• Lead readiness efforts for internal and external audits across stakeholders and partners.
• Coordinate internal and third-party stakeholders to resolve issues and prevent recurrence.

Connaissances

Quality strategy

CSV/CSA guidance

QMS design & implementation

Risk management

Audits & compliance

AI/ML governance

Cybersecurity awareness

Regulatory IT standards

Communication & collaboration

Formation

Bachelor's degree

Description du poste

Eli Lilly and Company, via Catalyze360, seeks a digital quality expert to own the quality strategy for internal and external systems. You will embed risk-based assurance and CSA practices into agile software delivery, guiding stakeholders toward submission-ready, audit-ready execution.

Lead readiness for audits, manage deviations and CAPAs, and drive QMS maturity, AI/ML governance, and cybersecurity posture across cross-functional teams to ensure compliant, scalable digital solutions.