At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Do you have a passion for understanding Artificial Intelligence systems and related quality controls? As the Senior Director of AI Quality Assurance, you’ll be at the forefront of shaping how AI technologies are effectively integrated into computer systems quality policies and procedures. Your expertise will drive best practices, influence policies, and ensure that our AI-driven systems meet global regulatory standards.

Lilly has embraced the responsible use of Artificial Intelligence (AI) solutions. With this technology, our talented Lilly teams are reimagining how our business works in a world powered by AI. AI presents unique risks and limitations that must be managed responsibly and effectively, particularly in the pharmaceutical environment.

The Senior Director of AI Quality Assurance is part of the Global Information Systems Quality (GISQ) organization. GISQ is accountable for defining Computer System Validation (CSV) standards and providing thought leadership for CSV activities across the Lilly enterprise. The GISQ team ensures compliance with corporate Computer System Validation (CSV) expectations for global computer systems, including GMP Computer systems, critical systems, and infrastructure platforms.

Key Objectives/Deliverables:

Policy Influence:

• Define and implement company-wide policies for AI use in computer systems in partnership with cross-functional teams, including legal, privacy, ethics and compliance, (with a greater focus on Gx P solutions)
• Advocate for ethical AI practices, bias mitigation, and transparency.
• Influence decision-making on AI adoption and integration.

Regulatory Compliance:

• Ensure AI systems adhere to global pharmaceutical regulations (e.g., FDA, EMA, MHRA).
• Implement best practices for computer system validation.
• Conduct self-assessments and partner with audit organizations on audits and assessments to maintain compliance.
• Ensure supported systems are validated in compliance with applicable policies and procedures.
• Assist in analyzing and mitigating potential risk with use of AI in computerized systems.

AI Testing Practices:

• Lead robust enterprise-wide testing strategies for AI systems.
• Collaborate with data scientists and software engineers to create validation strategies for AI algorithms.
• Ensure rigorous testing guidance for AI models, including performance, accuracy, and safety.

Training and Advisory Role:

• Provide expertise, establish best practices, and guide Tech@Lilly on AI validation, risk assessment, and compliance to Regulations and Lilly Policy
• Develop deep expertise in current and emerging laws and regulations related to Artificial Intelligence and Machine Learning
• Mentor and train others in Global Quality Compliance and Information Systems Quality focusing initially on deepening AI knowledge in everyday and Gx P use

Cross-Functional Collaboration:

• Partner with Tech@Lilly, Privacy, Legal and Global Quality Compliance teams to align AI initiatives.
• Collaborate with Tech@Lilly and Cyber Security regarding evolving technology and regulations

Minimum Requirements:

• Bachelor degree in a technology-related field such as Computer Science; or equivalent experience.
• 10 plus years’ experience in Automation/IT or computer system validation.
• 5 years’ experience in a pharmaceutical company, device manufacturer or related health industry.
• Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate.
• Experience with AI tools, use cases, and related testing and validation
• Experience in computer system quality assurance, preferably with AI/ML systems.

Additional Preferences:

• Knowledge of relevant regulations specific to Artificial Intelligence
• Understanding of process development and/or improvement (e.g., Six Sigma)
• Broad IT technical competency
• Ability to relate system use to potential impact to products and patients.
• Knowledge of regulations and Quality Systems’ Requirements
• Knowledge of IT Best Practices (e.g., LSEF, ITIL (IT Infrastructure Library))
• Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Other Information:
QA (Quality Assurance) Representative must successfully complete the Lilly CSQA Qualification Program

At Lilly, We Serve an Extraordinary Purpose. We Make a Difference for People Around the Globe by Discovering, Developing and Delivering Medicines That Help Them Live Longer, Healthier, More Active Lives. Not Only Do We Deliver Breakthrough Medications, But You Also Can Count on Us to Develop Creative Solutions to Support Communities Through Philanthropy and Volunteerism.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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