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Advisor, CSQA Representative – Catalyze360 Quality
Eli Lilly and Company. Serve as software quality subject-matter expert for internal and external systems and tools .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software quality management, including the design and implementation of quality management systems and risk management for digital systems. Proficient in interpreting regulations and standards, embedding quality into product delivery, and managing compliance and corrective actions.
Highest-signal resume keywords
Software Quality ManagementComputer System ValidationAI/ML Quality PracticesIT Regulations and StandardsCSQA Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management System DesignRisk AssessmentData AnalyticsSoftware Development Lifecycle EvaluationChange Control ManagementCorrective Action PlansIT ControlsCybersecurity Posture AssessmentProcess Improvement MethodsQuality 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 QualityDigital SystemsRegulated SoftwareData PrivacyQuality Improvement
Tech Stack
Tools & technologiesCloudCyber Security
About the role
Key responsibilities & impact- Serve as 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 portfolio
- Lead design and implementation of the quality management system, design controls, and risk-management artifacts
- Perform ongoing product and system risk assessments
- Recommend 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 through documented resolution
- 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 to inform decisions
- 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 Lilly and third-party teams to embed quality into CI/CD pipelines
- Act as Catalyze360 Quality's principal digital quality contact for external engagements
- Set expectations and build trusted 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
- Prior experience embedding quality into product delivery for regulated software
- Prior 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 waived where 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 in part 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, fitness benefits, and employee clubs and activities