Global Quality Systems Lead - Senior Principal

Eli Lilly and Company; Indianapolis (IN); Hybrid; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health, dental & vision

Paid time off

Job summary

Eli Lilly and Company in Indianapolis, IN, is seeking a Sr Principal (R4+) Global Quality Systems Lead. Hybrid role based at Lilly facilities in Indianapolis with international sites, requiring 10% travel. Lead QMS governance across operational controls and align processes with regulatory expectations to ensure quality and compliance.

The role supports quality system improvements, training, and performance insights across multiple functions, including manufacturing, R&D, and external suppliers.

Qualifications

• Bachelor's degree or equivalent in a scientific field, engineering, or related discipline.
• Minimum of 7 years of direct cGMP experience with strong knowledge of quality systems.
• English fluency; additional languages preferred.
• Experience in QC labs, cell/gene therapy, or parenteral manufacturing.

Responsibilities

• Provide oversight and consulting support to global process owners and networks for the interpretation and approval of quality system processes.
• Lead governance, management review, process monitoring, and prioritization to support QMS health.
• Develop and implement global quality system improvements with training and tools.
• Partner across manufacturing, suppliers, marketing quality operations, R&D, and Clinical Supply to standardize processes.
• Monitor regulatory developments and support inspection readiness to maintain compliance.

Skills

cGMP experience

Quality Systems

English fluent

Lean / continuous improvement

Presentation skills

Education

Bachelor's degree in science or engineering

Job description

Eli Lilly and Company in Indianapolis, IN, is seeking a Sr Principal (R4+) Global Quality Systems Lead. Hybrid role based at Lilly facilities in Indianapolis with international sites, requiring 10% travel. Lead QMS governance across operational controls and align processes with regulatory expectations to ensure quality and compliance.

The role supports quality system improvements, training, and performance insights across multiple functions, including manufacturing, R&D, and external suppliers.