Lilly is constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. The MMQA Representative oversees the material/vendor management system for the Lilly Advanced Therapies Site, ensuring compliance with Lilly Quality Standards.
Requirements
- 3+ years working in the pharmaceutical industry in Quality Assurance roles
- Previous experience working with and managing suppliers and materials in a regulated environment
- Previous experience with SAP or other inventory management systems
- Demonstrated knowledge and use of US, EU, Japanese and other regulations in the area of pharmaceutical manufacturing and material/supplier management
- Previous experience with deviation and change management systems
- Previous technical writing experience
- Technical aptitude and ability to train and mentor others
Responsibilities
- Collaborate with site staff and global resources to assist/conduct risk assessments and provide recommendations for Supplier/Service Provider approval
- Participate in periodic reviews of supplier performance
- Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements
- Represent the voice of quality to material management and supplier certification committees
- Provide operational oversight for incoming receipt, sampling, and testing
- Perform batch disposition of incoming materials/consumables
- Perform SAP data steward functions
Other
- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
- Previous facility or area start up experience
- 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
- Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
