Senior QA Lead, Analytical Foundry (GMP)

100 Eli Lilly and Company; United States; On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to ensure CGMP compliance and quality oversight for the Lilly Medicine Foundry project in Indiana.

You will lead analytical testing oversight, method verification, and quality documentation reviews in a fast-paced capital project environment. You’ll collaborate across quality organizations, mentor teams, and drive quality improvements while maintaining rigorous standards and regulatory readiness for scale-up and

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field.
• Minimum 5 years of technical laboratory experience with QA/ref quality systems.
• Knowledge of GMP expectations and quality management systems.

Responsibilities

• Provide quality oversight in analytical testing, including method verification, qualification, and validation.
• Ensure quality systems are in place and utilized; review deviations and changes.
• Lead investigations for deviations, stability issues, and OOS results.
• Perform QA review/approval of GMP documentation and ensure appropriate expert sign-off.
• Coordinate with Lilly quality organizations and promote a strong quality culture.

Skills

Quality Assurance

Analytical testing

GMP knowledge

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field

Job description

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to ensure CGMP compliance and quality oversight for the Lilly Medicine Foundry project in Indiana.

You will lead analytical testing oversight, method verification, and quality documentation reviews in a fast-paced capital project environment. You’ll collaborate across quality organizations, mentor teams, and drive quality improvements while maintaining rigorous standards and regulatory readiness for scale-up and