Senior/Principal QA Associate - Cell & Gene Therapies, External Manufacturing
Eli Lilly and Company
Summary
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 contract manufacturing activities and ensures adherence to Lilly GQS and cGMPs through deviation investigations, change control, documentation management, validations, and other relevant responsibilities. This position also supports inspection readiness, product launches, and is accountable for batch disposition, confirming all batches comply with specifications and regulatory requirements.
Job description
Responsibilities
- Serve as a liaison between 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 that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation
- Provide quality support of manufacturing operations with holistic review of key activities associated with or impacting the manufacturing processes
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
- Review and approve documents including, but not limited to, 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. Provide on-site support during inspections
- Participate in APR activities
- Participate in Post Launch Optimization Teams (PLOT)
Basic Requirements
- Bachelor's degree in 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
- Qualified applicants must be authorized to work in the United States on a full-time basis
Additional Preferences
- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- ASQ Certified
- Previous facility or area start up experience
- Previous 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
- Previous experience with Manufacturing Execution Systems
- Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills
- Demonstrated strong problem solving and decision-making skills
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others
Additional Information
- Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
- Position may require travel (10-25%)
Requirements
- Bachelor's degree in 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
- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- ASQ Certified
- Previous facility or area start up experience
- Previous experience with gene therapy drug substance processes
- Previous experience with Manufacturing Execution Systems
- Demonstrated ability to communicate with and influence cross-functional teams
- Demonstrated strong problem solving and decision-making skills
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs and Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.