External Manufacturing QA Lead — Pharma Quality & Compliance

BioSpace; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Health, dental, vision benefits

Vacation benefits

Well-being programs

Job summary

Lilly in Indianapolis, Indiana, is building a cutting-edge Lebanon Advanced Therapies manufacturing site. The LP2 External Manufacturing Quality Assurance Representative will lead quality oversight of contract manufacturers, ensuring Lilly GQS and cGMP compliance during selection, validation, and ongoing operations.

You will manage batch disposition, document reviews, and inspection readiness, while partnering across functions to drive quality and continuous improvement for both clinical and

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3+ years of pharmaceutical manufacturing QA experience.
• Authorized to work in the United States on a full-time basis; visa sponsorship not provided.

Responsibilities

• Serve as liaison between contract manufacturers and Lilly, providing quality oversight.
• Escalate quality issues to Lilly QA management.
• Establish and revise Quality Agreements with affiliates and customers.
• Ensure compliance with Quality Agreements and MRDs.
• Review and disposition batches, deviations, and testing documentation.
• Support regulatory inspections and on-site activities.
• Provide on-site support for manufacturing operations as required.
• Participate in APR and PLOT activities.

Skills

Quality Assurance

Regulatory knowledge

Leadership

Cross-functional collaboration

Technical writing

Mentoring

Education

Bachelor's degree

Tools

Manufacturing Execution Systems

Job description

Lilly in Indianapolis, Indiana, is building a cutting-edge Lebanon Advanced Therapies manufacturing site. The LP2 External Manufacturing Quality Assurance Representative will lead quality oversight of contract manufacturers, ensuring Lilly GQS and cGMP compliance during selection, validation, and ongoing operations.

You will manage batch disposition, document reviews, and inspection readiness, while partnering across functions to drive quality and continuous improvement for both clinical and