Senior Associate - External Manufacturing QA

About the Role

This is a unique opportunity to be part of the team for the startup of a greenfield manufacturing site at Lilly’s Lebanon, Indiana facility. The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative will demonstrate leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This role covers the process steps of selection, pre-validation/validation, ongoing operations, and termination, ensuring adherence to Lilly GQS and cGMPs.

Responsibilities

• Serve as a liaison between contract manufacturers (CMs) and Lilly, providing quality oversight and serving as the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Evaluate and disposition drug substance, drug product, and packaging batches, ensuring documented checks for Certificates of Testing, Certificates of Environmental Monitoring, deviations, changes, and batch documentation.
• Provide quality support of manufacturing operations with a holistic review of key activities impacting the manufacturing processes.
• Maintain awareness of external regulatory agency findings referencing product quality.
• Review and approve documents including procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
• Provide onsite support of manufacturing operations as required.
• Participate in regulatory inspection preparations with CMs and provide on-site support during inspections.
• Participate in Annual Product Review (APR) activities.
• Participate in Post Launch Optimization Teams (PLOT).

Requirements

• Bachelor's degree in a 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.
• Must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Preferred Qualifications

• Demonstrated knowledge and use of US, EU, Japan, and other regulations in pharmaceutical manufacturing.
• ASQ certification.
• Previous facility or area start-up experience.
• Experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging.
• Experience with Manufacturing Execution Systems.
• Strong problem-solving and decision-making skills.
• Previous technical writing experience.
• Technical aptitude and ability to train and mentor others.

Schedule

• Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office.
• Position may require travel (10-25%).

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits and flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities).