Advisor​/Sr. Advisor - CSQA Representative, CatalyzeQuality

Position: Advisor/Sr. Advisor - CSQA Representative, Catalyze360 Quality
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Organization Overview*
* Lilly Catalyze
360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly Tune Lab-Catalyze
360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.

** Job Summary*
* This role serves as the digital quality expert for Catalyze
360, covering both its internal and external systems and platforms. Operating with cross-organizational reach, this individual will set the digital quality strategy, embed risk-based assurance and Computer Software Assurance (CSA) practices into agile software delivery, and guide internal and external stakeholders for submission-ready, audit-ready execution.

** Key Responsibilities*
* + Serve as software quality subject-matter expert for internal and external systems and tools, including interpreting CSV standards and external regulations and translating them into practical quality requirements.

+ Own the digital quality strategy across the portfolio; lead design and implementation of the quality management system (QMS), design controls, and risk-management artifacts required to release, iterate, and monitor digital systems and tools.

+ Perform ongoing product and system risk assessments to identify compliance and performance gaps; recommend and drive corrective actions across engineering and product teams.

+ Manage deviations, change control (including AI/ML model change management), incident and issue management, root-cause investigations, and CAPAs for products and systems through documented resolution; serve as BQA/CSQA for critical internal business systems, including review and approval of related IT system documentation.

+ Lead readiness efforts across internal and external audits.

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

+ Deliver key quality data-compliance, conformance, model performance, cybersecurity posture, risks, and issues-to inform stakeholder decisions, and 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, applying product and agile delivery discipline to embed quality into CI/CD pipelines and build simple, workable solutions.

+ Act as Catalyze
360 Quality's principal digital quality point of contact for external engagements; set expectations and build trusted internal and external relationships across product, engineering, and subject matter experts.

** Minimum Requirements*
* + Bachelor's degree in a technology-related field (e.g., Computer Science, Software Engineering, Biomedical Engineering, Information Systems)

+ 6+ years of relevant industry experience in software quality for digital systems and tools or in Computer System Validation with meaningful exposure to software.

** Additional Skills/Preferences*
* ** _Experience_*
* + Prior experience with:

+ Embedding quality into product delivery for regulated software; and

+ 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 (may be waived where equivalent qualification is demonstrated).

+ Certifications relevant to digital quality and IT controls.

** _Skillsets_*
* + Working knowledge of IT regulations and standards.

+ Broad IT and product technical competency, including Artificial Intelligence / Machine Learning quality practices…