Global ATMP Quality Leader

Regulatory Jobs; Indianapolis (IN); On-site; USD 242,000 - 354,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Job summary

Lilly is seeking a Global ATMP Quality Leader to provide administrative and technical leadership for CGT quality across the enterprise. The role ensures compliance with GMP, quality standards, and regulatory requirements, overseeing QA/QC functions and external partnerships to enable seamless clinical and commercial supply.

The leader will build a scalable CGT quality organization, collaborate with multiple functions, and drive quality governance and inspections readiness, including support for

Qualifications

• Minimum of a Bachelor’s Degree in a science-related field.
• Minimum of 15 years in GMP manufacturing or quality operations.
• Minimum of 5 years in quality leadership with regulatory communications and inspections.
• Experience with biologics, cell therapy, gene therapy (AAV), or related ATMP modalities.

Responsibilities

• Oversee GMP QA and QC units for CGT modalities, including LP2 and external partners.
• Lead quality system improvements and cGMP alignment across sites.
• Provide governance for CGT quality sign-offs on regulatory submissions (IND, BLA, MAA/CMC).
• Ensure audit readiness and regulatory liaison support for inspections.
• Develop and execute quality strategies from facility design to commercialization.

Skills

Quality leadership

GMP knowledge

Regulatory liaison

Quality systems

Cross-functional leadership

Education

Bachelor’s Degree in Life Sciences

Tools

Quality Management System (QMS)

Job description

Lilly is seeking a Global ATMP Quality Leader to provide administrative and technical leadership for CGT quality across the enterprise. The role ensures compliance with GMP, quality standards, and regulatory requirements, overseeing QA/QC functions and external partnerships to enable seamless clinical and commercial supply.

The leader will build a scalable CGT quality organization, collaborate with multiple functions, and drive quality governance and inspections readiness, including support for