Quality Management System Deviation Lead

Quality Management System Deviation Lead

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.

The Quality Management System Deviation Lead provides strategic oversight and expertise for the global Deviation and CAPA processes, including Global Quality System standards, procedures, business processes, implementation tools and associated IT systems. Additionally, this role manages key global projects and priorities within the Global Quality System.

Key Objectives :

• Support general QMS Organizational Change Management activities, ongoing deployment support and troubleshooting support to ensure end users are proficient with system and process expectations.
• Facilitation of cross-functional education sessions, including Deviation and CAPA Communities of Practice for best practice and knowledge sharing and training programs to deepen the Deviation knowledge and expertise.
• Provide Root Cause Analysis subject matter expertise to ensure robust problem solving remains a strong core competency for all deviations.
• Monitor all Deviation and CAPA KPIs at Global level to assess health of deviation system and identify areas of opportunity across the enterprise.
• Lead Deviation and CAPA projects to support continuous improvement efforts, including revalidation and user acceptance testing for all system improvements implemented.
• Analyze Deviation and CAPA data to monitor site / function performance to ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Support sites / functions, as needed, to develop improvement plans.
• Act as Deviation and CAPA procedure SME and facilitate procedure updates when required to ensure consistent execution and / or as a result of regulatory feedback.
• Act as a SME for Deviation Artificial Intelligence tools, ensuring user feedback and learnings are considered to continuously improve the model outputs to improve quality of deviation write ups.
• Engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Deviations and CAPAs.

Basic Qualifications :

Additional Skills / Preferences :

Additional Information :