Global Quality Systems Lead – GxP & Compliance

Regulatory Jobs; Indianapolis (IN); On-site; USD 101,000 - 172,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits

401(k) program

Job summary

Lilly is seeking a Sr. Principal, Global Quality Systems Business Partner in Indianapolis. This high-impact role provides independent oversight of the Global Quality Management System, guiding GPOs and global partners to embed compliant quality decisions into daily operations.

The position requires 10+ years in pharma/biotech and strong leadership to drive quality improvements, risk management, and external engagements with regulators and industry forums.

Qualifications

• Bachelor's Degree preferred in a scientific field.
• 10+ years in pharmaceutical, biotech, or medical device setting.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Provide quality oversight and align quality strategy with operational goals for Global Quality Standards and Procedures.
• Coach and mentor colleagues on quality principles and regulatory expectations.
• Lead authoring and review of GxP documents to ensure compliance and quality attributes.
• Support audits, inspections, and CAPA activities; drive continuous improvement across the QMS.

Skills

Quality management

cGxPs expertise

FDA regulatory knowledge

Cross-functional leadership

Documentation management

Education

Bachelor's degree in scientific field

Job description

Lilly is seeking a Sr. Principal, Global Quality Systems Business Partner in Indianapolis. This high-impact role provides independent oversight of the Global Quality Management System, guiding GPOs and global partners to embed compliant quality decisions into daily operations.

The position requires 10+ years in pharma/biotech and strong leadership to drive quality improvements, risk management, and external engagements with regulators and industry forums.