Lilly
Healthcare
SeniorAssociate-ExternalManufacturingQA
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“Senior Associate - External Manufacturing QA at Lilly. Skills: External Manufacturing QA, Contract Manufacturers, Quality Assurance. Provide quality oversight of contract manufacturers. Manage daily contract manufacturing activities”
What You'll Achieve.
Ensure batches comply with specifications; Ensure batches comply with regulatory requirements
Industry & Context.
Problem solving; Decision making
10-25% travel, 8-12 hour shifts
What They're Looking For.
Must Have
Bachelor's degree in relevant field, 3+ years pharmaceutical manufacturing QA, QA oversight of contract manufacturers
Nice to Have
ASQ Certified, Facility or area start up experience, Experience with gene therapy processes, Experience with Manufacturing Execution Systems, Technical writing experience, Ability to train and mentor others
What You'll Do.
Provide quality oversight of contract manufacturers
Manage daily contract manufacturing activities
Ensure adherence to Lilly GQS
Ensure adherence to cGMPs
Manage deviation investigations
Manage change control
Support inspection readiness
Support product launches
Accountable for batch disposition
Confirm batches comply with specifications
Confirm batches comply with regulatory requirements
Provide quality support of manufacturing operations
Review and approve procedures
Review and approve master production records
Review and approve change control proposals
Review and approve deviations
Review and approve equipment qualifications
Review and approve analytical methods
Review and approve computerized system validations
Provide onsite support of manufacturing operations
Participate in regulatory inspection preparations
Provide on-site support during inspections
Participate in APR activities
Participate in Post Launch Optimization Teams
How You'll Work.
Team & Collaboration
Cross-functional teams; Alliance partners; Contract manufacturers; Internal customers
Communication Scope
Oral communication; Written communication
Process & Methodology
Quality System, Validation
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily co
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