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. Responsibilities include providing oversight and consulting to global process teams, leading governance and process monitoring, driving quality system improvements, and partnering across manufacturing, research, clinical supply, and external suppliers to manage risks and standardize processes. The role involves monitoring industry and regulatory developments, supporting inspection readiness, and 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.