Director, QA – Radiopharmaceuticals

Regulatory Jobs; Indianapolis (IN); On-site; USD 125,000 - 183,000; Full time

Benefits offered by this job

Competitive salary

Bonus program

Comprehensive benefits

Job summary

Lilly in Indianapolis, IN, seeks a QA Associate Director/Director to lead a multi-shift GMP operation producing radioligand compounds for commercial and late-stage use. You will manage QA personnel, ensure inspection readiness, and support external manufacturing partnerships.

The role requires 5+ years in pharmaceutical QA leadership, strong regulatory knowledge, and expertise in radiopharmaceutical processes. A site-wide Quality culture and cross-functional leadership are essential for success.

Qualifications

• Bachelor's degree in science, engineering, pharmaceutical field.
• 5+ years in pharmaceutical leadership with QA experience.
• Experience with radiopharmaceuticals preferred.
• Strong communication and training abilities.
• Regulatory inspection readiness experience.

Responsibilities

• Establish QA roles and authority for release and approvals.
• Lead governance to ensure cross-functional alignment and clear communication.
• Oversee Quality Management System design and site-specific controls.
• Supervise deviation investigations and root cause analysis.
• Support site leadership on objectives, budgets, and improvements.
• Collaborate with Technical Services on manufacturing process qualification.

Skills

QA leadership

Cross-functional collaboration

Regulatory knowledge

Aseptic radioligand ops

Quality Management Systems

Education

Bachelor's degree in science/engineering/pharma

Tools

Kneat

Veeva Vault

SAP

MS Office

Job description

Lilly in Indianapolis, IN, seeks a QA Associate Director/Director to lead a multi-shift GMP operation producing radioligand compounds for commercial and late-stage use. You will manage QA personnel, ensure inspection readiness, and support external manufacturing partnerships.

The role requires 5+ years in pharmaceutical QA leadership, strong regulatory knowledge, and expertise in radiopharmaceutical processes. A site-wide Quality culture and cross-functional leadership are essential for success.