Senior QA Lead – Analytical Quality Assurance

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to oversee laboratory activities at the Lilly Medicine Foundry. You will ensure cgmp compliance, data integrity, and quality documentation across external partners and internal labs.

The role focuses on method development, qualification, and continuous improvement of quality systems, with a strong emphasis on deviations investigations and KPI-driven governance.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related field.
• Minimum 5 years in a laboratory/QA role in pharma.
• Knowledge of GMP and quality management systems.
• Experience with analytical method development and validation.

Responsibilities

• Provide quality oversight of analytical testing and QA activities.
• Oversee method verification/qualification/validation.
• Ensure quality systems are in place and used.
• Investigate deviations, stability issues, and OOS results.
• Review GMP documentation and ensure proper approvals.
• Collaborate with Lilly quality organizations and drive quality projects.

Skills

Analytical testing

GMP

Quality systems

Method development

Documentation review

Deviations handling

Education

Bachelor's degree

Tools

Laboratory instruments

Job description

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to oversee laboratory activities at the Lilly Medicine Foundry. You will ensure cgmp compliance, data integrity, and quality documentation across external partners and internal labs.

The role focuses on method development, qualification, and continuous improvement of quality systems, with a strong emphasis on deviations investigations and KPI-driven governance.