QA Director, Radiopharmaceuticals – Site Quality & Compliance

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 125,000 - 183,000; Full time

Job summary

Lilly in Indianapolis is seeking a QA Associate Director/Director to lead a multi-shift GMP operation for radioligand production and oversee QA record review, release, and regulatory compliance. The role includes site leadership collaboration, training, and ensuring inspection readiness for global standards.

You will manage QA personnel, develop local procedures, and partner with Technical Services to qualify manufacturing changes, while maintaining a safe, compliant workplace and fostering a

Qualifications

• Bachelor's degree in science, engineering, pharmaceutical-related field or equivalent experience.
• 5+ years in pharmaceutical leadership with QA experience, including cross-functional collaboration.
• Experience with Radioligand Therapy (RLT) preferred.

Responsibilities

• Establish QA roles/responsibilities and authority for release.
• Lead governance to ensure inter-function connectivity and escalation.
• Maintain Quality Management System design, execution, and review.
• Supervise QA staff and drive training and development.
• Oversee record review, micro/QC labs oversight, and inspection readiness.

Skills

QA leadership

Radiopharmaceutical knowledge

Regulatory understanding

Interpersonal skills

People management

Education

Bachelor's degree in science/engineering/pharmaceutical-related field or equivalent experience

Tools

Kneat

Veeva Vault

SAP

Manufacturing execution systems

Microsoft Office

Job description

Lilly in Indianapolis is seeking a QA Associate Director/Director to lead a multi-shift GMP operation for radioligand production and oversee QA record review, release, and regulatory compliance. The role includes site leadership collaboration, training, and ensuring inspection readiness for global standards.

You will manage QA personnel, develop local procedures, and partner with Technical Services to qualify manufacturing changes, while maintaining a safe, compliant workplace and fostering a