Eli Lilly

Advisor/Sr. Advisor - CSQA Representative, Catalyze360 Quality

Eli Lilly • $129K — $211K *
Information Technology
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
  • 6+ years in software quality for digital systems or Computer System Validation (CSV).
  • Experience embedding quality in product delivery for regulated software.
  • Familiarity with CSV/CSA, IT controls, data privacy, and AI/ML governance.
  • Completion of CSQA Qualification Program preferred; waivers may apply based on qualifications.

Responsibilities

  • Act as the digital quality subject-matter expert for internal and external systems.
  • Lead the development of the digital quality strategy and quality management system (QMS).
  • Conduct product and system risk assessments to identify compliance gaps and initiate corrective actions.
  • Oversee change control, incident management, and root cause analyses for systems and products.
  • Prepare teams for internal and external audits, ensuring readiness in quality practices.
  • Coordinate with internal and external stakeholders to troubleshoot complex issues.
  • Provide critical quality data for stakeholder decision-making and promote best practices within teams.

Benefits

  • 401(k) plan with company-sponsored contributions.
  • Medical, dental, vision, and prescription drug benefits.
  • Life insurance and various time-off benefits.
  • Employee assistance programs and wellness initiatives.
  • Bonuses based on personal and company performance.
Full Job Description
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.


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

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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