Senior QA Lead: External Manufacturing for Gene Therapy

Regulatory Jobs; Lebanon (IN); Vor Ort; USD 65.000 - 169.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Zusammenfassung

Lilly’s Lebanon, Indiana site seeks an External Manufacturing Quality Assurance Representative to oversee contract manufacturers and alliance partners, ensuring cGMP compliance and effective issue resolution. The role supports inspections, batch disposition, and ongoing enhancements across validation and documentation processes.

Responsibilities include leading QA activities for supplier relationships, reviewing documents, and ensuring adherence to Lilly GQS. Travel up to 25% may be required.

Qualifikationen

• Bachelor's degree in relevant field (preference for scientific or engineering).
• 3+ years working in pharmaceutical manufacturing in Quality Assurance roles.
• Experience providing QA oversight of contract manufacturers.
• Authorized to work in the United States on a full-time basis (no visa sponsorship).

Aufgaben

• Liaise between contract manufacturers and Lilly, providing quality oversight and acting as the first contact for quality issues.
• Escalate quality issues to Lilly QA management.
• Establish and revise Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs.
• Evaluate and disposition drug substance, drug product, and packaging batches per testing certificates and deviations.

Kenntnisse

QA oversight

Regulatory compliance

Process validation

Documentation

Root cause analysis

Ausbildung

Bachelor's degree in science/engineering

ASQ Certified

Jobbeschreibung

Lilly’s Lebanon, Indiana site seeks an External Manufacturing Quality Assurance Representative to oversee contract manufacturers and alliance partners, ensuring cGMP compliance and effective issue resolution. The role supports inspections, batch disposition, and ongoing enhancements across validation and documentation processes.

Responsibilities include leading QA activities for supplier relationships, reviewing documents, and ensuring adherence to Lilly GQS. Travel up to 25% may be required.