Senior Early-Phase QA Scientist (GMP)

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

Job summary

Lilly seeks an experienced QA professional to provide day-to-day quality oversight of Early Phase teams and external partners, ensuring GMP compliance for pre-commercialization activities and clinical trial materials through Phase II.

The role requires reviewing manufacturing documentation, managing deviations and investigations, and coordinating with CMOs, labs, and suppliers to sustain regulatory readiness. Travel may be required.

Qualifications

• Minimum 5 years professional experience.
• Experience with global clinical trial cGMP regulations.
• Broad technical and quality knowledge across API, drug product manufacturing, clinical trial packaging, analytical labs & ADC.

Responsibilities

• Provide day-to-day QA oversight for Early Phase teams and external partners.
• Ensure GMP compliance and regulatory readiness for clinical materials through Phase II.
• Review/make decisions on manufacturing documentation, deviations, investigations and change controls.
• Coordinate investigations of deviations and complaints; manage GMP documentation and regulatory commitments.
• Contribute QA input to development plans and oversee qualification of CMOs, packagers, labs, vendors and supply chain partners.
• Support on-site activities at partner sites for manufacturing, packaging and labeling of IMPs as needed.

Skills

Quality Assurance

GMP/cGMP

Documentation

Root Cause Analysis

Data Integrity

Change Management

Analytical Skills

Communication Skills

Problem Solving

Technical Troubleshooting

Education

Bachelor's degree in Science/Engineering

Tools

Computer systems

Job description

Lilly seeks an experienced QA professional to provide day-to-day quality oversight of Early Phase teams and external partners, ensuring GMP compliance for pre-commercialization activities and clinical trial materials through Phase II.

The role requires reviewing manufacturing documentation, managing deviations and investigations, and coordinating with CMOs, labs, and suppliers to sustain regulatory readiness. Travel may be required.