Associate, Quality Assurance, Process Manufacturing

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first‑ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

This position will initially support quality functions associated with Lilly Technical Center in Indianapolis. The position will then transfer to supporting startup activities at the Lilly Medicine Foundry and on‑site quality support of cGMP operations. The initial position will be fluid and dynamic as we endeavor to implement the necessary systems and business processes required to support GMP operations and build the site culture.

This will require significant collaboration, creativity and resilience.

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross‑functional teams, facilitate decision making and drive progress.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross‑functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Influence and oversee Facility, Utility, Maintenance and Equipment (FUME) Qualification/Maintenance/Calibration programs.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.

• BA/BS degree in Engineering, Science, or related field with a minimum of 3 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Understand GMP requirements for early phase development and manufacturing and application of quality management systems.
• Prior experience in equipment/utilities qualification, calibration and maintenance.
• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

• Demonstrated relevant experience in a cGMP facility.
• Relevant industry experience in high‑paced working environment.
• Demonstrated strong oral and written communication skills.
• Critical thinking and technical problem‑solving skills, including root cause analysis/troubleshooting skills.
• Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
• Ability to establish key relationships and influence peers and business partners.
• Ability to identify and prioritize issues and develop & implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Demonstrated attention to detail.

• Position Location - Initial location:
  Indianapolis, IN US;
  Future:
  Lebanon IN Lilly Medicine Foundry Operations
• Travel Percentage: 5% - 15%
• May be required to provide on‑call support outside of normal working hours including nights, weekends, and holidays.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual…