Senior Advisor – CSQA Representative, Catalyze360 Quality

Eli Lilly and Company

. Serve as the software quality subject-matter expert for internal and external systems and tools .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $129,000 - $211,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality management, including the design and implementation of quality management systems and risk management for digital systems. Proficient in embedding quality into product delivery, ensuring compliance with IT regulations, and leading cross-functional teams in quality improvement initiatives.

Highest-signal resume keywords

Software Quality ManagementComputer System ValidationAI/ML Quality PracticesQuality Management System DesignIT Regulations and Standards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software QualityRisk AssessmentData AnalyticsChange ControlQuality ImprovementIT ControlsCSV StandardsCybersecurity PostureProcess ImprovementQuality Data Analysis

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsNegotiation SkillsAutonomous Operation

Tools & Technologies

Microsoft OfficeCI/CD PipelinesLSEFITILSix Sigma

Certifications & Qualifications

CSQA Qualification ProgramDigital Quality Certifications

Industry Keywords

Software Development LifecycleRegulated SoftwareIT Best PracticesData PrivacyQuality Management

Tech Stack

Tools & technologies

CloudCyber Security

About the role

Key responsibilities & impact

Serve as the software quality subject-matter expert for internal and external systems and tools
Interpret CSV standards and external regulations and translate them into practical quality requirements
Own the digital quality strategy across the Catalyze360 portfolio
Lead design and implementation of the quality management system, design controls, and risk-management artifacts
Perform product and system risk assessments and drive corrective actions across engineering and product teams
Manage deviations, change control including AI/ML model change management, incidents, issues, root-cause investigations, and CAPAs
Serve as BQA/CSQA for critical internal business systems and review and approve related IT system documentation
Lead readiness efforts for internal and external audits
Coordinate internal stakeholders and third parties to resolve complex issues and prevent recurrence
Deliver quality data on compliance, conformance, model performance, cybersecurity posture, risks, and issues
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 to embed quality into CI/CD pipelines
Serve as Catalyze360 Quality's principal digital quality contact for external engagements
Set expectations and build relationships across product, engineering, and subject-matter experts

Requirements

What you’ll need

Bachelor's degree in a technology-related field, such as Computer Science, Software Engineering, Biomedical Engineering, or Information Systems
6+ years of relevant industry experience in software quality for digital systems and tools or Computer System Validation with meaningful exposure to software
Experience embedding quality into product delivery for regulated software
Experience advising or consulting external companies on software quality, CSV/CSA, IT-controls, data privacy, and AI/ML governance
Completion of the CSQA Qualification Program upon hire, unless equivalent qualification is demonstrated
Certifications relevant to digital quality and IT controls
Working knowledge of IT regulations and standards
Broad IT and product technical competency, including AI/ML quality practices, information security, programming, data analytics, and cloud
Knowledge of modern software delivery practices, IT best practices such as LSEF and ITIL, and process-improvement methods such as Six Sigma
Excellent written and verbal communication, interpersonal, organizational, and negotiation skills
Ability to work effectively at all organizational levels and with external partners
Ability to operate autonomously across internal and external stakeholders
Proficiency with Microsoft Office
Proficient written and spoken English
Ability to travel up to 10% in the US and/or OUS
Relocation is not provided for this role

Benefits

Comp & perks

Company bonus depending on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program and fitness benefits
Employee clubs and activities