Global CGT Quality Leader for ATMP Excellence

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

Job summary

Lilly in Indianapolis seeks a Global ATMPS Quality Leader to shape CGT quality strategy from clinical development through commercialization. You will oversee GMP QA and QC, manage CDMO relationships, and ensure compliance with GQS, GMP, and global regulations to support clinical and commercial supply.

This role leads a growing ATMP quality organization, drives quality systems improvements, supports regulatory submissions (IND, BLA, MAA), and partners with PR&D, Manufacturing, Regulatory, and

Qualifications

• Bachelor's degree in science-related field.
• 15+ years of GMP manufacturing or quality operations.
• 5+ years of quality leadership with regulatory communications/inspections.

Responsibilities

• Oversee GMP QA and QC units for CGT modalities (LP2 site and acquisitions).
• Lead quality systems improvements and new Quality Standards.
• Ensure cGMP compliance and appropriate quality systems for CGT manufacturing.
• Define facility design, qualification, and process validation for CGT sites.
• Provide governance for CGT quality and sign-off of regulatory submissions (IND, BLA, MAA).
• Collaborate with PR&D, Manufacturing, Regulatory, and external partners to meet quality requirements.

Skills

Quality leadership

GMP/QC oversight

Regulatory submissions

Quality systems

Stakeholder comms

Education

Bachelor's degree in science

Tools

Quality Management Systems

GXP compliance

Job description

Lilly in Indianapolis seeks a Global ATMPS Quality Leader to shape CGT quality strategy from clinical development through commercialization. You will oversee GMP QA and QC, manage CDMO relationships, and ensure compliance with GQS, GMP, and global regulations to support clinical and commercial supply.

This role leads a growing ATMP quality organization, drives quality systems improvements, supports regulatory submissions (IND, BLA, MAA), and partners with PR&D, Manufacturing, Regulatory, and