Global CGT Quality Leader

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

Benefits offered by this job

Bonus eligible

401(k) and pension

Medical, dental, vision benefits

Vacation benefits

Well-being programs

Job summary

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to oversee CGT quality across the enterprise, including QA/QC oversight for CGT modalities and CDMOs, ensuring cGMP compliance and readiness for regulatory submissions from development to commercialization.

The role builds a scalable ATMP quality organization, aligns with PR&D, Manufacturing, Regulatory, and external partners to deliver quality systems, audits, and continuous improvement across the CGT portfolio.

Qualifications

• 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 with regulatory communications and inspections.
• Previous QA experience with biologics, cell therapy, gene therapy (AAV), or related ATMP modalities.
• Strong leadership with ability to scale organizations.
• Understanding of FDA, EMA, ICH regulatory requirements and cGMPs for biologics/ATMPs.
• Proven teamwork, communication, and cross-functional influence.

Responsibilities

• Oversee GMP QA and QC units supporting CGT modalities and partners.
• Provide modality-specific quality guidance across the enterprise.
• Build and scale the Global CGT Quality organization and manage resourcing and audits.
• Serve as regulatory liaison and lead inspection readiness and responses.
• Lead strategic budgeting and quality planning aligned with CGT milestones.

Skills

Quality leadership

GMP knowledge

Regulatory submissions

Quality systems

Cross-functional leadership

Quality governance

Education

Bachelor’s Degree in science

Advanced degree (MS/PhD/PharmD)

Tools

Quality Management Systems (QMS)

GxP documentation tools

Job description

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to oversee CGT quality across the enterprise, including QA/QC oversight for CGT modalities and CDMOs, ensuring cGMP compliance and readiness for regulatory submissions from development to commercialization.

The role builds a scalable ATMP quality organization, aligns with PR&D, Manufacturing, Regulatory, and external partners to deliver quality systems, audits, and continuous improvement across the CGT portfolio.