Global Senior GxP Quality Audit Lead

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 129 000 - 211 000; Plein temps

Résumé du poste

Lilly in Indianapolis is seeking a Senior Advisor within Global Quality Auditing to assure quality across development, research, and commercialization by leading audits and providing technical guidance. This role emphasizes deep GxP expertise and proactive risk mitigation.

This position requires extensive collaboration with third-party organizations, senior leadership, and regulatory authorities, with up to 40% travel domestically and internationally; compensation reflects experience and

Qualifications

• Bachelor’s degree in physical or biological sciences, engineering, or a related discipline.
• Minimum 10 years of experience within the pharmaceutical industry working in a GCP/GLP area.
• Minimum 5 years of experience working with Third Party Organizations, such as CROs, Clinical Vendors/Service Providers, Pre-Clinical/Clinical/GLP Labs, Clinics, and clinical supply organizations.
• Minimum of 5 years of experience reviewing/assessing/auditing Pre-Clinical/Clinical data/reports.

Responsabilités

• Plan and lead complex audits and assessments of internal and external operations.
• Escalate risks and ensure compliance with company standards and regulatory guidelines.
• Educate leadership on the impact of quality and data integrity issues and drive robust corrective actions.
• Collaborate with global teams and regulatory authorities; support inspections.

Connaissances

GxP Auditing

Regulatory Compliance

Quality Assurance

Project Management

Cross-functional Collaboration

Formation

Bachelor's degree in physical or biological sciences, engineering or a related scientific/technical discipline

Description du poste

Lilly in Indianapolis is seeking a Senior Advisor within Global Quality Auditing to assure quality across development, research, and commercialization by leading audits and providing technical guidance. This role emphasizes deep GxP expertise and proactive risk mitigation.

This position requires extensive collaboration with third-party organizations, senior leadership, and regulatory authorities, with up to 40% travel domestically and internationally; compensation reflects experience and