Sr Principal Global Quality Systems Lead

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.  Job Position Overview: The Sr Principal (R4+) – Global Quality Systems Lead will provide oversight and support of QMS processes under Global Process Ownership for non-Quality owned processes.  The role additionally ensures alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The role supports the QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar of the QMS framework. Additionally, the GQS Lead will support QMS excellence by supporting the aligning of processes with business priorities, ensuring compliance, and driving quality improvements.

Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for the interpretation, implementation, review, and approval of global quality system processes and documents. Lead and continuously improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar to support timely decisions, consistent execution, and QMS health. Assess, develop, and implement global quality system improvements, including standards, practices, training, implementation tools, effectiveness measures, and performance insights aligned with regulatory, industry, and company expectations. Partner across manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, Clinical Supply, and other enterprise functions to manage process risks, strengthen capability, and enable standardized global business processes. Monitor regulatory and industry developments, support inspection readiness, and engage with external organizations to help maintain compliance and influence quality-related policies and requirements.

Education Level: Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline.

Minimum of 7 years of direct cGMP experience, with strong knowledge of cGMP requirements and quality systems. Demonstrated experience in at least one relevant area or modality, such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing. Certifications: N/A. Licenses: N/A. Language Requirements: Fluent in English; additional languages are preferred.

Testing: N/A. Additional Skills/ Preferences: Previous experience with Quality Risk Management and global quality system governance. Previous experience with process and equipment validation, cleaning and sterilization, GMP utilities, sterility assurance, or bioburden controls. Detailed knowledge of U.S. and European GMPs, ICH, PIC/S, and WHO expectations. Formal training in Lean, continuous improvement methodologies, or Quality Risk Management. Proven ability to interpret standards, understand customer needs, solve complex problems, and apply requirements across different situations. Proven ability to work independently and collaboratively, communicate constructive feedback, and develop and deliver effective presentations to varied audiences.