Global ATMP Quality Leader (CGT) – GMP & Compliance

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 242,000 - 354,000; Full time

Job summary

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to shape CGT quality across the enterprise, from clinical development through commercialization, ensuring cGMP compliance and regulatory readiness.

This role leads the CGT QA/QC organization, partnering with PR&D, Manufacturing, Regulatory, and external partners to drive quality strategy for ATMP modalities such as AAV and cell therapy, while provisioning leadership and strategic direction for continuous improvement.

Qualifications

• Minimum of a Bachelor’s Degree in a science-related field.
• Minimum of 15 years of experience in GMP manufacturing or quality operations.
• Minimum of 5 years of quality leadership experience.
• Experience with biologics, cell therapy, gene therapy (AAV), or related advanced therapy modalities.
• Demonstrated strong leadership and ability to influence cross-functionally.
• Understanding of FDA/EMA/ICH CGMP requirements for biological/ATMP products.

Responsibilities

• Oversee GMP QA and QC units for CGT modalities and collaborate with PR&D, Manufacturing, Regulatory, and external partners for compliance.
• Provide quality oversight and escalation with senior management for CGT modalities.
• Develop, scale, and lead the Global CGT Quality organization and talent across sites.
• Ensure regulatory inspections readiness and manage responses to findings.
• Lead strategic budgeting, planning, and integration of acquired assets into CGT quality operations.

Skills

Quality leadership

GMP knowledge

Cross-functional collaboration

Regulatory liaison

Quality systems

Strategic planning

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to shape CGT quality across the enterprise, from clinical development through commercialization, ensuring cGMP compliance and regulatory readiness.

This role leads the CGT QA/QC organization, partnering with PR&D, Manufacturing, Regulatory, and external partners to drive quality strategy for ATMP modalities such as AAV and cell therapy, while provisioning leadership and strategic direction for continuous improvement.