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.
Organization Overview:
Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. Located in Lebanon, IN, the Lebanon Advanced Therapies (LP2) 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 gene therapy manufacturing site in a highly cross-functional environment. The successful candidate will demonstrate leadership, teamwork, and technical expertise in the onboarding of materials/suppliers required for the Site mission and then provide ongoing oversight for the program.
Position Description:
The MMQA Representative oversees the material/vendor management system for the Lilly Advanced Therapies Site, ensuring compliance with Lilly Quality Standards. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Responsibilities include program execution/maintenance, improvement, and support for incoming material receipt, batch release, and warehouse operations.
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
- Review/redline GMP documents including specifications and procedures
- Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
- Support regulatory inspections by providing documentation and SME support
Basic Requirements:
- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
- 3+ years working in the pharmaceutical industry in Quality Assurance roles
- Qualified applicants 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences:
- 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 facility or area start up experience
- Previous experience with deviation and change management 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%) or potentially a short duration assignment at another Lilly site to establish material management system knowledge
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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