Associate Director - Clinical Operations Quality Assurance

Company Name

Eli Lilly and Company

Job Description

The Associate Director, Clinical Operations Quality Assurance role at Eli Lilly and Company is integral to the global QA function, ensuring the GCP Quality Management System is well-defined and executed. This position leads GCP QA activities, establishing procedures for sponsor oversight of internal operations and contracted clinical investigations. It ensures clinical sites and third parties are qualified according to risk-based standards.

Key Responsibilities

• Manage the GCP external audit program
• Provide risk-based quality oversight

Requirements

• A Bachelor's degree in STEM
• A minimum of 5 years of QA experience in pharmaceutical GCP operations