Senior Global Quality Auditor (GxP)

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Job summary

Lilly in Indianapolis seeks a Senior Advisor in Global Quality Auditing to lead complex audits across development, non-clinical and clinical research, business development, product commercialization and pharmacovigilance. This role ensures GxP operations comply with company standards and regulatory expectations.

You will mentor teams, drive risk mitigation, review metrics, and collaborate with global partners. Extensive travel up to 40% may be required.

Qualifications

• Bachelor’s degree in physical or biological sciences, engineering or related field.
• Minimum of 10 years in pharmaceutical industry in a GCP/GLP area.
• Minimum of 5 years with third party organizations and auditing Pre-Clinical/Clinical data.

Responsibilities

• Plan and lead complex audits and assessments across GxP areas.
• Elevate risks and compliance issues as needed and ensure corrective actions.
• Provide technical guidance to leadership and cross-functional teams.
• Maintain knowledge of applicable regulations and industry standards.

Skills

GxP auditing

Regulatory compliance

Project management

Communication skills

ASQ CQA

Education

Bachelor’s degree in physical or biological sciences, engineering or related

Job description

Lilly in Indianapolis seeks a Senior Advisor in Global Quality Auditing to lead complex audits across development, non-clinical and clinical research, business development, product commercialization and pharmacovigilance. This role ensures GxP operations comply with company standards and regulatory expectations.

You will mentor teams, drive risk mitigation, review metrics, and collaborate with global partners. Extensive travel up to 40% may be required.