Senior Advisor – CSQA Representative, Catalyze360 Quality

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Act as the software quality subject matter expert for both internal and external systems and tools.

• Interpret CSV standards and external regulations, converting them into actionable quality requirements.

• Take ownership of the digital quality strategy across the Catalyze360 portfolio.

• Lead the design and implementation of the quality management system, design controls, and risk management artifacts.

• Conduct product and system risk assessments and guide corrective actions within engineering and product teams.

• Oversee 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 associated IT system documentation.

• Lead preparation efforts for both internal and external audits.

• Coordinate with internal stakeholders and third parties to resolve complex issues and prevent recurrence.

• Provide quality data on compliance, conformance, model performance, cybersecurity posture, risks, and issues.

• Champion quality improvement and the harmonization of best practices across internal teams and partner engagements.

• Assess software development lifecycle, QMS maturity, and AI/ML governance.

• Mobilize cross-functional teams within Lilly and third parties to integrate quality into CI/CD pipelines.

• Act as the primary digital quality contact for external engagements for Catalyze360 Quality.

• Establish expectations and foster relationships across product, engineering, and subject-matter experts.

⛳️ Requirements

• Bachelor’s degree in a technology-related field, such as Computer Science, Software Engineering, Biomedical Engineering, or Information Systems.

• Over 6 years of relevant industry experience in software quality for digital systems and tools, or Computer System Validation, with significant exposure to software.

• Proven experience embedding quality into product delivery for regulated software.

• Background in 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 pertinent to digital quality and IT controls.

• Working knowledge of IT regulations and standards.

• Comprehensive IT and product technical competency, including AI/ML quality practices, information security, programming, data analytics, and cloud technologies.

• Familiarity with modern software delivery practices, IT best practices such as LSEF and ITIL, and process improvement methodologies like Six Sigma.

• Exceptional written and verbal communication, interpersonal, organizational, and negotiation skills.

• Ability to work effectively at all organizational levels and with external partners.

• Capacity to operate independently across internal and external stakeholders.

• Proficiency in Microsoft Office.

• Proficient in written and spoken English.

• Willingness to travel up to 10% within the US and/or internationally.

• Relocation assistance is not provided for this role.

🏝️ Benefits

• Company bonus based on company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• 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 an employee assistance program and fitness benefits.

• Opportunities for employee clubs and activities.