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Global Computer Systems Quality Advisor

3 months ago

Indianapolis, United States Eli Lilly and Company Full time

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.

Information Systems Quality - Global Computer Systems Quality AI (Artificial Intelligence) Advisor

Position Description:

Do you have a passion for understanding Artificial Intelligence systems and related quality controls?

As a Computer System Quality Associate specializing in AI, you'll be at the forefront of shaping how AI technologies are 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 to be used responsibly and effectively particularly in the pharmaceutical environment.

The Global Computer Systems Quality Assurance (CSQA) Artificial Intelligence (AI) Advisor is part of the Information Systems Quality (ISQ) organization. ISQ is accountable for defining Computer System Validation (CSV) standards and providing thought leadership for CSV activities across the Lilly enterprise. The ISQ team ensures compliance to 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 teamsAdvocate 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.

AI Testing Practices:

Develop and implement robust enterprise-wide testing strategies for AI systems.Lead and influence teams to use best practicesCollaborate 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 PolicyFoster a culture of quality excellence and continuous improvement within the organization.Assist in analyzing and mitigating potential risk with use of AI in computerized systems.Develop deep expertise in current and emerging laws and regulations related to Artificial Intelligence and Machine LearningMentor and train others in Information Systems Quality focusing initially on deepening AI knowledge in everyday and GxP use

Cross-Functional Collaboration:

Partner with Tech@Lilly, Privacy, Legal and Global Quality Compliance teams to align AI initiatives.Facilitate knowledge sharing across departments.Collaborate with Tech@Lilly and Information Security regarding evolving technology and regulationsLead quality related projects/ initiatives to increase efficiency and drive quality culture

Minimum Requirements:

Bachelor (4 yr. College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 3+ years’ experience in Automation/IT or computer system validation)Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate.5 years’ experience in a pharmaceutical company, device manufacturer or related health industry.Experience with AI tools, use cases, and related testing and validationExperience in computer system quality assurance, preferably with AI/ML systems.

Additional Preferences:

Knowledge of relevant regulations specific to Artificial IntelligenceUnderstanding of process development and/or improvement (e.g., Six Sigma)Broad IT technical competencyAbility to relate system use to potential impact to products and patients.Knowledge of regulations and Lilly 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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