Senior Associate - External Manufacturing QA
Eli Lilly and Company
August 30, 2026
On-site
Lebanon, IN
Operations
Responsibilities:
- Serve as a liaison between contract manufacturers (CMs) and Lilly; initial point of contact for quality-related issues
- Escalate quality issues at CMs to Lilly QA management
- Assist in establishing and revising 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 by confirming documented checks for Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes, and batch documentation
- Provide quality support via holistic review of key manufacturing activities impacting processes
- Maintain awareness of external regulatory agency findings related to product quality
- Review and approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations
- Provide onsite support as required
- Participate in regulatory inspection preparations and provide on-site inspection support
- Participate in APR activities and Post Launch Optimization Teams (PLOT)
Basic Requirements:
- Bachelor’s degree in a relevant field (preference for scientific or engineering)
- 3+ years in pharmaceutical manufacturing Quality Assurance roles
- Prior experience providing QA oversight of contract manufacturers
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas
Additional Preferences:
- Knowledge of US/EU/Japan pharmaceutical manufacturing regulations
- ASQ Certification
- Facility/area startup experience
- Gene therapy process experience (drug substance and/or drug product)
- Manufacturing Execution Systems experience
- Strong oral/written communication; ability to influence cross-functional teams
- Strong problem-solving and decision-making
- Technical writing experience
- Ability to train and mentor others
Additional Information:
- 8–12 hour shifts, Monday–Friday, Lebanon, IN
- Travel 10–25%
Benefits/Compensation:
- Anticipated wage: $65,250 - $169,400; company bonus eligibility and comprehensive benefits (as described)
Application instructions:
- Complete Lilly’s workplace accommodation request form if you need accommodation to submit a resume.
- Serve as a liaison between contract manufacturers (CMs) and Lilly; initial point of contact for quality-related issues
- Escalate quality issues at CMs to Lilly QA management
- Assist in establishing and revising 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 by confirming documented checks for Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes, and batch documentation
- Provide quality support via holistic review of key manufacturing activities impacting processes
- Maintain awareness of external regulatory agency findings related to product quality
- Review and approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations
- Provide onsite support as required
- Participate in regulatory inspection preparations and provide on-site inspection support
- Participate in APR activities and Post Launch Optimization Teams (PLOT)
Basic Requirements:
- Bachelor’s degree in a relevant field (preference for scientific or engineering)
- 3+ years in pharmaceutical manufacturing Quality Assurance roles
- Prior experience providing QA oversight of contract manufacturers
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas
Additional Preferences:
- Knowledge of US/EU/Japan pharmaceutical manufacturing regulations
- ASQ Certification
- Facility/area startup experience
- Gene therapy process experience (drug substance and/or drug product)
- Manufacturing Execution Systems experience
- Strong oral/written communication; ability to influence cross-functional teams
- Strong problem-solving and decision-making
- Technical writing experience
- Ability to train and mentor others
Additional Information:
- 8–12 hour shifts, Monday–Friday, Lebanon, IN
- Travel 10–25%
Benefits/Compensation:
- Anticipated wage: $65,250 - $169,400; company bonus eligibility and comprehensive benefits (as described)
Application instructions:
- Complete Lilly’s workplace accommodation request form if you need accommodation to submit a resume.