Sr. Principal, Global Quality Systems Business Partner

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Sr. Principal, Global Quality Systems Business Partner is a technical leadership position providing independent oversight of the Global Quality Management System (QMS) Pillars and their corresponding processes (GPOs and global/functional partners), while also acting as the primary quality liaison providing hands‑on quality leadership and strategic guidance. This role ensures product quality, regulatory compliance, and continuous improvement are embedded in day‑to‑day business decisions, while supporting a broad range of QMS pillar process topics and global/functional partners in the development, execution, monitoring of process health, and continuous improvement of the global standards and procedures, ensuring standardized, simple, and compliant processes.

This role consults GPOs, global/functional partners, and network/site leadership on quality assurance matters and proactively assures compliance with regulatory expectations and scientific principles to align quality strategy with operational and business goals. The role engages externally for identifying industry trends and supporting Lilly’s external influence initiatives, and engages and influences leadership, global/functional partners, and mentors colleagues in quality principles and culture to develop capabilities within the organization.

Key Objectives/Deliverables

• Provide quality oversight and partner with assigned pillar GPOs and Level 2 (L2) process global/functional associates and leadership to align quality strategy with operational and business goals, supporting the design and continuous improvement of Global Quality Standards, Global Procedures, and related documents and training.
• Provide guidance, coaching, and interpretation of quality expectations to GPOs, global/functional associates, and leadership to ensure robust compliance in managing key technical, quality, and compliance issues.
• Effectively author, review, or approve GxP documents to ensure quality attributes are met and compliant with quality standards through closure (e.g., strategies, standards, procedures, training, protocols, reports, qualifications, specifications, deviations, change controls, CAPA).
• Provide analysis of evolving regulatory and industry expectations, education, training, implementation tools, and emerging technologies to promote simplicity and consistency, ensuring compliance with cGMP, FDA, and other applicable global regulatory requirements.
• Support the monitoring of the health of the QMS through analysis of KPIs, quality metrics, and other performance data, reporting trends and risks to leadership, and support the identification and implementation of continuous improvement initiatives.
• Lead and/or support the assessment, development, and implementation of critical and complex global projects within cross‑functional working groups in support of continual and significant quality improvements or technical agenda objectives.
• Engage externally with regulatory or industry forums to share expertise within and outside Lilly through technical publications and presentations
• Support internal/external audits and…