Sr Principal Global Quality Systems Lead

Role:
The Sr Principal (R4+) – Global Quality Systems Lead oversees and supports QMS processes under Global Process Ownership, ensuring alignment with the broader Quality Management System for non-Quality processes.

• Providing oversight and consulting to global process teams
• Leading governance and process monitoring
• Driving quality system improvements
• Partnering across manufacturing, research, clinical supply, and external suppliers to manage risks and standardize processes
• Monitoring industry and regulatory developments
• Supporting inspection readiness
• Influencing quality policies

• Bachelor’s in a scientific, engineering, or related field
• Minimum 7 years of cGMP experience with knowledge in quality systems, particularly in areas like Quality Control, cell and gene therapy, or parenteral manufacturing
• Preferred skills include experience with risk management, process validation, GMP utilities, and knowledge of ICH, PIC/S, and WHO standards
• Additional qualifications may include formal training in Lean or continuous improvement, and experience supporting facility or process validation

High Value:
Focus on biopharma manufacturing, quality system governance, and compliance in cGMP environments, with some travel (~10%) and hybrid work setup based in Indianapolis, Indiana or other Lilly sites.