Quality Assurance Operations Associate, GMP Manufacturing

Regulatory Jobs; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, is advancing the Lilly Medicine Foundry—a new center for advanced manufacturing and drug development. The Foundry will grow into a full-scale GMP facility, requiring rigorous QA support on the manufacturing floor and cross-functional collaboration across teams.

The role focuses on day-to-day QA oversight of GMP operations, change management, and investigations, with startup activities leading to a dynamic, evolving environment in Indiana.

Qualifications

• 2+ years of technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Understand GMP requirements for early phase development and manufacturing and in application of quality management systems.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor visas.

Responsibilities

• Participate in creating and maintaining a safe work environment.
• Foster a strong collaborative quality culture including maintaining open communication and promoting teamwork with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support GMP activities.
• Review GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross-functionally with the plant teams to provide operational support, and issue management.
• Assist with inspection readiness activities.
• Effectively communicate with internal and external stakeholders.

Skills

GMP knowledge

Quality systems

Cross-functional collaboration

Attention to detail

Communication skills

Education

BS in Engineering/Science

Job description

Lilly, headquartered in Indianapolis, Indiana, is advancing the Lilly Medicine Foundry—a new center for advanced manufacturing and drug development. The Foundry will grow into a full-scale GMP facility, requiring rigorous QA support on the manufacturing floor and cross-functional collaboration across teams.

The role focuses on day-to-day QA oversight of GMP operations, change management, and investigations, with startup activities leading to a dynamic, evolving environment in Indiana.