Global CGT Quality AVP — ATMP Strategy & Compliance

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

Benefits offered by this job

Company bonus

Comprehensive benefits

Job summary

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to establish and execute the quality strategy for CGT modalities from clinical development through commercialization.

The role leads GMP QA/QC, drives regulatory submissions, and partners across PR&D, Manufacturing, Regulatory, and external CDMOs to ensure compliance and readiness, while building a scalable ATMP quality organization.

Qualifications

• Bachelor’s degree in a science-related field (Chemistry, Biology, Microbiology, Engineering, or Life Sciences).
• Minimum of 15 years of GMP manufacturing or quality operations experience.
• Minimum of 5 years of quality leadership experience with regulatory communications.
• Experience with biologics, cell therapy, gene therapy (AAV) or ATMPs.
• Strong leadership, ability to scale organizations and manage cross-functional teams.
• Knowledge of FDA/EMA/ICH regulatory expectations for CGT and cGMP.

Responsibilities

• Oversight of GMP QA and QC units supporting CGT modalities, including external partnerships; ensure quality systems and compliance.
• Provide leadership for CGT quality across the enterprise and escalation of quality issues to senior management.
• Build, scale, and develop the Global CGT Quality organization and ensure qualified sites for operations.
• Act as regulatory liaison and lead audit/inspection readiness for CGT quality.
• Drive strategic planning and budget for CGT quality, integrating new modalities and acquisitions.

Skills

GMP knowledge

Quality leadership

Regulatory inspections

CGT/ATMP expertise

Cross-functional collaboration

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

Lilly in Indianapolis is seeking a Global ATMPS Quality Leader to establish and execute the quality strategy for CGT modalities from clinical development through commercialization.

The role leads GMP QA/QC, drives regulatory submissions, and partners across PR&D, Manufacturing, Regulatory, and external CDMOs to ensure compliance and readiness, while building a scalable ATMP quality organization.