Global Quality Systems Lead

Job Summary

To support the evolution of quality management processes, the full-time Sr Principal Global Quality Systems Lead will oversee QMS processes, ensure compliance, and drive quality improvements in a hybrid work environment based out of Indianapolis, Indiana or other specified locations.

Key Responsibilities

• Provide oversight and consulting support for the implementation and review of global quality system processes and documents
• Lead governance and process monitoring across the Operational Controls pillar to ensure timely decisions and QMS health
• Assess and implement global quality system improvements aligned with regulatory and company expectations

Required Qualifications

• 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 quality systems
• Demonstrated experience in areas such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing
• Fluent in English; additional languages are preferred
• Previous experience with Quality Risk Management and global quality system governance