Senior QA Lead - External Manufacturing (Gene Therapy)

712 Lly Lebanon Adv Therapies; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) pension

Vacation benefits

Health, dental, vision benefits

Flexible benefits program

Life insurance

Job summary

Lilly's Lebanon Advanced Therapies site in Lebanon, IN seeks a dedicated External Manufacturing QA Representative to provide quality oversight of contract manufacturers from selection through validation and batch disposition. You will manage deviations, changes, and MRDs, support inspections, and ensure regulatory compliance across CMs.

The role requires 3+ years in pharma QA, a relevant bachelor's degree, and US work authorization, with travel up to 25% as needed.

Qualifications

• Bachelor's degree in a relevant field (science or engineering preferred).
• 3+ years in pharmaceutical manufacturing QA roles.
• Experience providing QA oversight of contract manufacturers.
• Authorized to work in the United States full-time.

Responsibilities

• Serve as liaison between contract manufacturers and Lilly, providing quality oversight.
• Escalate quality issues at contract manufacturers to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Evaluate and disposition drug substance, drug product, and packaging batches with documented checks.
• Provide quality support of manufacturing operations with holistic review of key activities.
• Maintain awareness of external regulatory findings referencing product quality.
• Review and approve documents including procedures, master production records, deviations, changes, and validations.
• Provide onsite support of manufacturing operations as required.
• Participate in regulatory inspection preparations with contract manufacturers.
• Provide on-site support during inspections and participate in APR and PLOT activities.

Skills

Quality oversight

Cross-functional communication

Problem solving

Education

Bachelor's degree in relevant field

Tools

Manufacturing Execution Systems

Job description

Lilly's Lebanon Advanced Therapies site in Lebanon, IN seeks a dedicated External Manufacturing QA Representative to provide quality oversight of contract manufacturers from selection through validation and batch disposition. You will manage deviations, changes, and MRDs, support inspections, and ensure regulatory compliance across CMs.

The role requires 3+ years in pharma QA, a relevant bachelor's degree, and US work authorization, with travel up to 25% as needed.