Gene Therapy QA Lead — External Manufacturing

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

Job summary

Lilly in Lebanon, IN is seeking an External Manufacturing QA Representative to lead quality oversight of contract manufacturers for LP2. You will guide pre-validation/validation activities, support inspections, and ensure adherence to Lilly GQS and cGMPs across manufacturing steps for clinical and commercial supply.

The role requires strong QA leadership, collaboration with alliance partners, and ongoing documentation review to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in relevant field (preference for scientific or engineering field).
• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
• Previous experience providing Quality Assurance oversight of contract manufacturers.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor visas.

Responsibilities

• Serve as a 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 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 affecting product quality.
• Review and approve documents including procedures, master production records, deviations, and validations.
• Provide onsite support of manufacturing operations as required.
• Participate in regulatory inspection preparations with contract manufacturers and provide on-site support during inspections.
• Participate in APR and PLOT activities.

Skills

Quality Oversight

Regulatory Knowledge

GxP Compliance

Cross-functional Liaison

Education

Bachelor’s degree in relevant field

Job description

Lilly in Lebanon, IN is seeking an External Manufacturing QA Representative to lead quality oversight of contract manufacturers for LP2. You will guide pre-validation/validation activities, support inspections, and ensure adherence to Lilly GQS and cGMPs across manufacturing steps for clinical and commercial supply.

The role requires strong QA leadership, collaboration with alliance partners, and ongoing documentation review to ensure product quality and regulatory compliance.