Senior/Principal QA Associate - Cell & Gene Therapies, External Manufacturing

Lilly • Lebanon, IN

19h • $66,000 - $171,600 • Onsite

About The Position

Lilly is constructing a new advanced therapies manufacturing facility in Lebanon, Indiana, focused on new modalities including gene therapy. The role offers an opportunity to help start up a greenfield site and establish its quality system for clinical and commercial supply.

The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative provides quality oversight of contract manufacturers and alliance partners throughout their lifecycle, from selection and validation through ongoing operations and termination. The role maintains relationships with external partners and internal customers, manages daily contract manufacturing activities, and helps ensure compliance with Lilly GQS, cGMPs, quality agreements, and regulatory requirements. Responsibilities include batch disposition, quality documentation and investigations, inspection readiness, and support for product launches and manufacturing operations.

The position is based at the Lebanon, Indiana office and may require 10–25% travel. The schedule may involve 8–12-hour shifts Monday through Friday. The anticipated wage range is $66,000–$171,600. Full-time employees may be eligible for a company bonus and a comprehensive benefits program.

Requirements

• Bachelor’s degree in a relevant field.
• At least 3 years of experience in pharmaceutical manufacturing industry Quality Assurance roles.
• Previous experience providing Quality Assurance oversight of contract manufacturers.
• Authorization to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• A scientific or engineering field for the bachelor’s degree is preferred.
• Knowledge and use of US, EU, Japan, and other pharmaceutical manufacturing regulations.
• ASQ certification.
• Previous facility or area startup experience.
• Experience with gene therapy drug substance processes such as equipment preparation, virus preparation or banking, inoculation, or purification; and/or drug product processes such as formulation, filling/visual inspection, and packaging.
• Experience with Manufacturing Execution Systems.
• Ability to communicate with and influence cross-functional teams, with strong oral and written communication skills.
• Strong problem-solving and decision-making skills.
• Technical writing experience.
• Technical aptitude and ability to train and mentor others.

Responsibilities

• Serve as a liaison between contract manufacturers and Lilly, providing quality oversight and acting as the initial contact for quality-related issues.
• Escalate contract manufacturer quality issues to Lilly QA management.
• Assist with 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, checking certificates, deviations, changes, and batch documentation.
• Provide quality support for manufacturing operations, including holistic review of key activities that affect manufacturing processes.
• Monitor external regulatory agency findings that reference product quality.
• Review and approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
• Provide onsite support for manufacturing operations as required.
• Participate in regulatory inspection preparations with contract manufacturers and provide onsite inspection support.
• Participate in APR activities.
• Participate in Post Launch Optimization Teams (PLOT).

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior