Global ATMP Quality VP: Lead CGT Quality Strategy

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

Job summary

Lilly, headquartered in Indianapolis, seeks a Global ATMPS Quality Leader to provide administrative and technical leadership for CGT quality across the enterprise. The role establishes and executes the CGT quality strategy from clinical development through commercialization.

The leader will oversee GMP QA/QC, support regulatory submissions and inspections, and build a scalable quality organization. Travel and cross-functional collaboration are essential to success.

Qualifications

• Minimum of a Bachelor’s Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.
• Minimum of 15 years of GMP manufacturing or quality operations experience in pharma/biotech.
• Minimum of 5 years in quality leadership with regulatory communications/inspections.

Responsibilities

• Provide GMP QA/QC oversight for CGT modalities and external partners.
• Lead regulatory submissions, inspections, and commitments with timely QA reviews.
• Develop and scale CGT quality organization, ensuring cGMP compliance across sites.

Skills

Quality leadership

GMP knowledge

Regulatory liaison

Cross-functional leadership

Quality systems

Audits & inspections

Process validation

Education

Bachelor's Degree in a science-related field

Advanced degree (MS/PhD) in a relevant discipline

Tools

Quality management systems

Job description

Lilly, headquartered in Indianapolis, seeks a Global ATMPS Quality Leader to provide administrative and technical leadership for CGT quality across the enterprise. The role establishes and executes the CGT quality strategy from clinical development through commercialization.

The leader will oversee GMP QA/QC, support regulatory submissions and inspections, and build a scalable quality organization. Travel and cross-functional collaboration are essential to success.