Lilly Medicine Foundry – Senior Technical Lead – Quality Systems, Automation & AI

Regulatory Jobs; Lebanon (IN); On-site; USD 129,000 - 231,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Health benefits

Vacation benefits

Well-being programs

Job summary

Lilly Medicines Foundry in Indiana seeks a Senior Technical Leader to drive digital quality system automation and AI-enabled solutions within a GMP-regulated setting. You will lead the architecture and roadmap for quality processes, prototype AI applications, and collaborate across Global Quality teams.

You will own test automation, CI/CD pipelines, and automated code management tools such as JIRA, ALM, and GitHub, ensuring high standards and regulatory alignment across the site and beyond.

Qualifications

• Demonstrated technical leadership in digital quality systems and AI/Analytics in regulated environments.
• Hands-on expertise with test automation, CI/CD pipelines, and automated code management.
• Experience driving digital innovation including AI-enabled solutions in a GMP-regulated business.

Responsibilities

• Own the technical roadmap and architecture standards for digital transformation and Quality process automation at Medicine Foundry.
• Expand SME knowledge of Digital Forms, Global QMS, and Quality AI/Analytics with Global/PRD Quality teams.
• Lead test automation strategy and CI/CD pipelines; govern code management across JIRA, ALM, GitHub.
• Drive digital innovation across Technology teams in Quality space; collaborate with cross-functional partners across CTI and M&Q.
• Communicate technical strategy and roadmaps to both technical and business stakeholders.

Skills

Technical leadership

AI/Analytics solutions

GxP/regulatory knowledge

Communication

Education

Bachelor’s degree

Tools

JIRA

ALM

GitHub

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.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

What You’ll Be Doing:

As a Senior Technical Leader at the Lilly Medicine Foundry, you will serve as both a hands-on technical practitioner and the functional lead for service management, test automation, technology and business quality process automation, GMP readiness, compliance and AI enablement. This role sits at the intersection of systems configuration, GxP compliance, and operational collaboration requiring someone who can drive alignment across Technology at Lilly, process science, engineering, operations, and quality stakeholders.

At the Lilly Medicine Foundry, you will be the key technical resource for the quality systems and processes for Technology at Lilly and the business. In addition, you will prototype, evaluate and implement emerging AI/ML and generative AI use cases relevant to quality process automation, documentation, and similar workflows.

You will be instrumental in delivering IT automation and AI solutions that meet stringent quality standards and facilitate the site’s mission and vision.

Key responsibilities include:

• Own the technical roadmap and architecture standards for the digital transformation and Quality process automation at Medicine Foundry.
• Expanding subject matter expertise in core systems including Digital Forms, Global QMS system(s), and Global Quality AI and Analytics solutions, partnering with Global and PRD Quality teams.
• Leading test automation strategy and owning CI/CD automated pipelines and automated code management practices, leveraging tools such as JIRA, ALM, and GitHub.
• Driving digital innovation into the Business Quality space through the adoption and implementation of Global and local Quality AI and automation efforts
• Soliciting and coordinating innovation across Technology at Lilly teams operating in the Quality space, including cross-functional engagements primarily across CTI and M&Q

How You Will Succeed:

• Establish yourself as the go-to technical authority for digital solutions across the Business Quality space, shaping architecture, design, and implementation decisions.
• Build and continuously expand SME-level knowledge of Digital Forms, Global QMS system(s), and Global Quality AI and Analytics solutions, partnering closely with Global and PRD Quality teams.
• Champion test automation and robust CI/CD pipeline practices, ensuring reliable, well-governed automated code management across JIRA, ALM, GitHub, and related tooling.
• Proactively solicit innovation ideas and collaboration opportunities across Technology at Lilly teams operating in the Quality space, forging cross-functional partnerships across CTI and M&Q.
• Communicate technical strategy and solution roadmaps clearly to both technical and business stakeholders, building consensus and trust.
• Anticipate emerging risks and opportunities in the digital quality landscape, escalating and resolving issues proactively with Global and PRD Quality partners.
• Stay current on trends and innovation in quality technology and AI by engaging with external forums, conferences, and internal communities of practice.

What You Should Bring

• Demonstrated technical leadership experience across digital quality systems, ideally including Digital Forms, Global QMS platforms, and Quality AI/Analytics solutions in a regulated environment.
• Hands-on expertise with test automation frameworks, CI/CD pipeline design, and automated code management using tools such as JIRA, ALM, and GitHub.
• Experience driving digital innovation initiatives, including AI-enabled solutions, within a Quality or GxP-regulated business function.
• Strong collaboration skills with a track record of partnering across global and cross-functional teams (e.g., Global/PRD Quality, Clinical, Technology at Lilly) to advance shared innovation goals.
• Ability to solicit, evaluate, and champion innovative ideas across a broad technical community, translating them into scoped digital initiatives.
• Solid understanding of GxP/quality compliance requirements as they apply to digital solutions and automation.
• Excellent communication skills, with the ability to translate complex technical concepts for both technical and non-technical audiences.
• Comfort operating in an evolving, fast-paced environment, managing multiple concurrent priorities and driving initiatives from concept to delivery.

Basic Qualifications:

• Bachelor’s degree
• Minimum of 5+ years of experience in quality, validation, or technology roles supporting GMP-regulated systems, with exposure to manufacturing or laboratory operations.
• Minimum of 4+ years of experience supporting or leading Computer System Validation (CSV) or Computer Software Assurance (CSA) activities in a GMP-regulated environment (GMP, GLP, or GCP).

Preferred Qualifications:

• Experience working within or alongside a pharmaceutical manufacturing operation.

Other Information:

• Initial location will be based out of Indianapolis, Indiana.
• Permanent location will be at the new Lilly Medicines Foundry in Lebanon, Indiana.

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 - $231,000

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