Global Computer Systems Quality Advisor - Artificial Intelligence

Key Skills

Aartificial intelligence, Algorithms, Effective communication skills, IT, Lean Six Sigma, Machine learning techniques

Job Description

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 teams
• 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.

AI Testing Practices:

• Develop and implement robust enterprise-wide testing strategies for AI systems.
• Lead and influence teams to use best practices
• 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
• Foster 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 Learning
• Mentor 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 regulations
• Lead 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 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 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

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