Senior Associate - External Manufacturing QA
Eli Lilly and Company
August 30, 2026
Full-time
On-site
Lebanon, IN
Operations
Role: The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative oversees quality aspects of contract manufacturing for Lilly's new gene therapy manufacturing facility. Responsibilities include providing quality oversight of CMs, managing deviations, change controls, documentation, batch disposition, and regulatory inspection support. The role also involves establishing and maintaining quality agreements, ensuring compliance with Lilly GQS and cGMPs, and supporting manufacturing operations and product launches.
Requirements: Bachelor’s degree in a scientific or engineering field; 3+ years in pharmaceutical manufacturing QA, with previous experience overseeing contract manufacturers. Qualified to work full-time in the US, with strong knowledge of US, EU, Japan regulations, and familiarity with gene therapy processes is preferred.
Preferred: Knowledge of global pharma regulations, certification (e.g., ASQ), experience with gene therapy processes, manufacturing execution systems, and technical writing. Strong communication, problem-solving, and mentorship skills are desirable.
HighValue: Focus on gene therapy, next-generation manufacturing technologies, clinical and commercial supply, and regulatory compliance. The position involves onsite work in Lebanon, IN, with 10-25% travel expected.
Requirements: Bachelor’s degree in a scientific or engineering field; 3+ years in pharmaceutical manufacturing QA, with previous experience overseeing contract manufacturers. Qualified to work full-time in the US, with strong knowledge of US, EU, Japan regulations, and familiarity with gene therapy processes is preferred.
Preferred: Knowledge of global pharma regulations, certification (e.g., ASQ), experience with gene therapy processes, manufacturing execution systems, and technical writing. Strong communication, problem-solving, and mentorship skills are desirable.
HighValue: Focus on gene therapy, next-generation manufacturing technologies, clinical and commercial supply, and regulatory compliance. The position involves onsite work in Lebanon, IN, with 10-25% travel expected.