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.
Responsibilities
- 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
Requirements
- 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
HighValue: 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.
#J-18808-LjbffrSr Principal Global Quality Systems Lead in concord at Unknown Company
This position is listed as full time and hybrid.