QA Associate Director: API Manufacturing

Eli Lilly and Company; Lebanon (KY); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Company bonus

Job summary

Lilly is seeking a Quality Assurance Associate Director to provide quality oversight of LP1 API manufacturing and to lead QA teams in ensuring regulatory compliance and continuous improvement. The role focuses on commissioning readiness, issue resolution, and cross-functional collaboration.

The candidate will guide QA staff, mentor manufacturing representatives, and ensure adherence to cGMP and global quality standards across the site in Lebanon, Indiana.

Qualifications

• BS in Engineering or science related field (required).
• 5+ years in CGMP manufacturing.
• Experience leading QA teams and coordinating with cross functional groups.

Responsibilities

• Provide direct quality oversight to LP1 manufacturing and guide QA staff.
• Lead resolution of quality issues and support inspection readiness.
• Coordinate with cross functional teams to achieve QA objectives.
• Prepare for internal and external regulatory inspections and ensure site QA systems align with standards.
• Coach and mentor QA manufacturing representatives in QA support and investigations.

Skills

Leadership

QA oversight

Problem solving

Communication

Technical aptitude

Regulatory knowledge

Root cause investigations

Training/mentoring

Education

BS in Engineering or science related field

Tools

CGMP

Job description

Lilly is seeking a Quality Assurance Associate Director to provide quality oversight of LP1 API manufacturing and to lead QA teams in ensuring regulatory compliance and continuous improvement. The role focuses on commissioning readiness, issue resolution, and cross-functional collaboration.

The candidate will guide QA staff, mentor manufacturing representatives, and ensure adherence to cGMP and global quality standards across the site in Lebanon, Indiana.