Global Quality Systems Leader - Strategic Compliance

Eli Lilly and Company; Indianapolis (IN); On-site; USD 101,000 - 172,000; Full time

Benefits offered by this job

Bonus potential

Comprehensive benefits

401(k) retirement plan

Job summary

Lilly seeks a Sr. Principal, Global Quality Systems Business Partner to lead independent oversight of the Global Quality Management System. You will guide GPOs, ensure GMP compliance, and drive process health across global partners in a fast-paced environment.

You will mentor teams, author and review GxP documents, and partner with leadership to embed quality into day-to-day decisions while advancing continuous improvement initiatives across Lilly's global operations.

Qualifications

• Bachelor’s degree in a scientific field (preferred).
• 10+ years in pharmaceutical, biotech, or medical device settings.
• Authorized to work in the United States full-time.

Responsibilities

• Provide quality oversight with pillar GPOs and partners to align quality strategy with goals.
• Coach and interpret quality expectations to ensure robust compliance.
• Author, review, or approve GxP documents ensuring quality standards.
• Analyze regulatory trends and promote simple, compliant processes.
• Monitor QMS health via KPIs and drive continuous improvements.
• Lead or support global projects for quality enhancements.
• Engage regulators and industry groups to share expertise.
• Support audits and regulatory inspections, including responses.
• Mentor colleagues on QMS, quality culture, and regulatory expectations.
• Identify risks and propose solutions across the QMS and control strategies.

Skills

Leadership

Quality management systems

Regulatory compliance

GxP knowledge

Project management

Cross-functional collaboration

Documentation & training

Quality risk management

Strategic thinking

Communication

Education

Bachelor's degree in a scientific field

Tools

GxP documentation tools

CAPA tracking

Job description

Lilly seeks a Sr. Principal, Global Quality Systems Business Partner to lead independent oversight of the Global Quality Management System. You will guide GPOs, ensure GMP compliance, and drive process health across global partners in a fast-paced environment.

You will mentor teams, author and review GxP documents, and partner with leadership to embed quality into day-to-day decisions while advancing continuous improvement initiatives across Lilly's global operations.