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

BioSpace; Lebanon (IN); Sur place; USD 129 000 - 231 000; Plein temps

Résumé du poste

Lilly Medicine Foundry in Indianapolis, Indiana, is seeking a Senior Technical Leader to own the technical roadmap for Quality process automation, AI enablement, and GMP readiness. You will balance hands-on engineering with leadership across Technology, process science, engineering, operations, and quality stakeholders.

You will prototype and implement AI/ML use cases for quality workflows, manage CI/CD pipelines, and ensure compliant digital solutions across JIRA, ALM, GitHub.

Qualifications

• Bachelor’s degree in a relevant field with 5+ years in GMP‑regulated quality, validation or tech roles.
• Experience leading CSV/CSA activities in GMP environments (GMP/GLP/GCP).
• Demonstrated technical leadership across digital quality systems and AI/Analytics solutions.

Responsabilités

• Own the technical roadmap and architecture standards for digital transformation and Quality process automation.
• Expand SME knowledge of Digital Forms, Global QMS systems, and Quality AI/Analytics with Global/PRD teams.
• Lead test automation strategy and CI/CD pipelines using JIRA, ALM, GitHub.
• Drive digital innovation in Quality through AI adoption and automation across Lilly teams.
• Collaborate across CTI and M&Q to solicit and coordinate innovative digital initiatives.

Connaissances

Technical leadership

GxP compliance

AI/Automation

Test automation

CI/CD

JIRA

ALM

GitHub

Cross-functional collaboration

Formation

Bachelor's degree

Outils

JIRA

ALM

GitHub

Digital Forms

Global QMS

Description du poste

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 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).

Benefits

• 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
• well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance)

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

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