Global CGT Quality Leader

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 242,000 - 354,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Job summary

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to build and scale the CGT Quality organization, overseeing QA/QC, regulatory submissions, and supplier oversight across sites. You will partner with PR&D, LRM, Manufacturing, TS/MS, Device Development and Regulatory to ensure cGMP compliance, drive quality improvements, and support clinical and commercial supply.

Minimum requirements include a Bachelor’s degree plus 15 years in GMP manufacturing or quality, with at least 5 years in

Qualifications

• Bachelor’s degree in a science-related field; advanced degree preferred.
• 15+ years GMP manufacturing or quality operations experience.
• 5+ years in quality leadership with regulatory communications.
• Experience with biologics, cell therapy, or gene therapy (ATMP).

Responsibilities

• Oversee GMP QA and QC for CGT modalities across sites.
• Lead regulatory submissions, audits, and inspections.
• Build and scale CGT Quality organization with senior leadership.
• Partner with PR&D, Manufacturing, and Regulatory to ensure cGMP compliance.

Skills

GMP knowledge

Quality leadership

Regulatory inspections

Cross-functional collaboration

CGT knowledge

Education

Bachelor's degree in science-related field

Advanced degree (MS/PhD) preferred

Tools

Quality Management Systems

Regulatory filing support

Job description

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to build and scale the CGT Quality organization, overseeing QA/QC, regulatory submissions, and supplier oversight across sites. You will partner with PR&D, LRM, Manufacturing, TS/MS, Device Development and Regulatory to ensure cGMP compliance, drive quality improvements, and support clinical and commercial supply.

Minimum requirements include a Bachelor’s degree plus 15 years in GMP manufacturing or quality, with at least 5 years in