Advisor/Sr. Advisor - CSQA Representative, Catalyze360 Quality

Regulatory Jobs; United States; Hybrid; USD 129,000 - 211,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Medical, dental, vision coverage

Well-being programs

Job summary

Lilly Catalyze360 is seeking a Digital Quality Expert to lead the digital quality strategy across internal and external systems. You will embed risk-based assurance, CSA practices, and readiness for audits within agile software delivery, guiding cross-organizational stakeholders to submission-ready, audit-ready execution.

The role requires CSQA or equivalent, 6+ years in software quality, and strong knowledge of IT controls, data privacy, and AI/ML governance. Travel up to 10% is possible.

Qualifications

• Bachelor's degree in a technology-related field (e.g., CS, SWE, BME, IS).
• 6+ years in software quality for digital systems or CSV/CSA.
• CSQA certification or equivalent qualification preferred.

Responsibilities

• Serve as software quality expert for internal and external systems.
• Own digital quality strategy; implement QMS and risk artifacts.
• Conduct risk assessments; drive corrective actions with teams.
• Manage deviations, change control, incidents, CAPAs.
• Lead readiness for internal and external audits.
• Collaborate with stakeholders to ensure audit-ready submissions.
• Monitor model governance and cybersecurity posture.
• Embed quality into CI/CD pipelines and agile delivery.

Skills

Quality governance

AI/ML governance

Regulated software

Cross-functional

Risk management

Cybersecurity

CI/CD quality

Education

Bachelor's degree in a technology-related field

CSQA Certification

Tools

CSQA Certification

ITIL

Six Sigma

Job description

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 Catalyze360 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 TuneLab—Catalyze360 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 Catalyze360, 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 Catalyze360 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 (training data lineage, bias auditing, model monitoring), Information Security, Programming, Data Analytics, and Cloud.

• Knowledge of modern software delivery practices, IT best practices (e.g., LSEF, ITIL), and process‑improvement methods (e.g., Six Sigma).

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

• Ability to work effectively at all levels of the organization, internally and with external partners.

• Demonstrated ability to operate autonomously across internal and external stakeholders.

• Proficiency with Microsoft Office; proficient written and spoken English.

Additional Information

• Travel up to 10% US and/or OUS.

• Relocation is not provided for this role.

• Lilly may provide support for or sponsor work authorization or visas for this role for internal applicants only.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$129,000 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly