Advisor​/Sr. Advisor - Inspection Lead

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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.

Join Lilly’s Global Information Systems Quality (GISQ) team as a GISQ Inspection Lead, where you will drive inspection readiness across GISQ and Tech this role, you will establish a sustainable framework for proactive inspection support, knowledge management, and cross-functional collaboration. Your efforts will ensure that GISQ and Tech@Lilly are consistently prepared for regulatory inspections and that inspection-related knowledge is institutionalized and continuously improved.

By maintaining Lilly’s high standards of compliance and operational excellence, you help safeguard patient safety, regulatory trust, and business agility.

You will partner with Tech@Lilly, Global Quality Compliance, Global Medical Quality Organization and others providing expert consultation and influence on Lilly’s computer system inspection readiness. This role provides high visibility across global functions and leadership, allowing you to influence the future of digital quality assurance at Lilly and collaborate with cross-functional quality and IT experts.

Be part of a mission-driven company improving lives worldwide.



Key Responsibilities

Inspection Readiness Strategy & Execution

• Lead the development and execution of a comprehensive inspection readiness strategy tailored to Tech@Lilly systems and operations.
• Establish virtual Inspection Team within GISQ to serve as the GISQ lead during inspections, ensuring timely and accurate responses to regulatory inquiries.
• Coordinate, support and lead mock inspections, readiness assessments, and real-time inspection activities.

• Build and maintain the GISQ Inspection Readiness Knowledge Base, including storyboards, FAQs, templates, and historical inspection data.
• Ensure the knowledge base is accessible, current, and aligned with evolving regulatory expectations.
• Facilitate training and onboarding sessions to embed inspection readiness culture across GISQ and Tech@Lilly.
• Collaborate with RCPMR (Regulatory Compliance and Post Market Reporting Team) team to utilize and maintain the global Regulatory Intelligence dashboard.
• Utilize external benchmarking to anticipate regulatory inspection needs and best practices for inspection support.

• Partner with Tech@Lilly and Global Medicines Quality Organization (GMQO) inspection leads to align inspection processes, share best practices, and drive consistency.
• Collaborate with system owners, validation leads, and global and site quality representatives to ensure readiness is embedded in daily operations.
• Represent GISQ in global quality forums and inspection readiness working groups.
• Collaborate with RCPMR team to ensure Global Quality Systems (GQS) is aligned on inspectional support and remediation post inspection.

• Identify and address gaps in inspection support processes.
• Lead continuous improvement initiatives to enhance inspection preparedness, reduce risk, and improve response agility.
• Identify and implement artificial intelligence and/ or automation of inspection readiness processes.
• Monitor regulatory trends and inspection outcomes to inform process enhancements.
• Active participation in After Action Reviews as appropriate and also to actively participate in the Preapproval Inspection/Pre-License inspection readiness process.

• Establish a centralized, user-friendly…