Associate, Quality Assurance, Manufacturing Operations, Lilly Medicine Foundry

About the role

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a first-of-its-kind center combining research and manufacturing in a single location. The Foundry is currently in design and construction, with startup phase anticipated completion in 2027. This role will initially be fluid and dynamic, supporting the delivery of the Foundry, building a new organization, developing and implementing systems and business processes for GMP operations, and establishing site culture. Once startup activities are complete, the Quality Assurance Associate, Manufacturing Operations will perform production floor QA support functions, including day-to-day Quality oversight of GMP operations, change management, and investigation reviews.

Initial location: Indianapolis, IN (future location: Lebanon, IN). Travel: 5% - 15%. May require on-call support outside normal working hours, including nights, weekends, and holidays.

Responsibilities

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

Requirements

• BA/BS degree in Engineering, Science, or related field.
• Minimum of 2 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
• Understanding of GMP requirements for early-phase development and manufacturing, and application of quality management systems.
• Authorized to work in the United States on a full-time basis (Lilly will not sponsor work authorization or visas for this role).

Preferred Qualifications

• Effective project and time management skills.
• Ability to prioritize and handle multiple concurrent tasks.
• Strong problem-solving, verbal reasoning, attention to detail, critical thinking, and analytical competencies.
• Excellent oral and written communication skills.
• Strong organization and self-management skills.
• Relevant experience in a cGMP facility.
• Industry experience in a high-paced working environment.
• Critical thinking and technical problem-solving skills, including root cause analysis and troubleshooting.
• Flexibility to adjust quickly to frequent changes and altered priorities.
• Ability to identify, prioritize, and resolve issues.
• High learning agility and ability to deal with ambiguity and uncertainty.
• Demonstrated attention to detail.

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time employees are also eligible for a company bonus (based on company and individual performance).

Benefits

• Comprehensive medical, dental, vision, and prescription drug benefits.
• Company-sponsored 401(k) and pension plans.
• Vacation benefits and flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).