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. 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 Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly's new Lebanon, Indiana (LP2) site. The QA Operational Support position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas:
- ATMP Gene Therapy Drug Substance Manufacturing
- ATMP Gene Therapy Parenteral Manufacturing
- QC Laboratory
- Packaging
- Warehouse Logistics
- Facility, Utility and Maintenance
Responsibilities: - Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
- Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design
- Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
- Actively participate in required design reviews and final design qualification activities
- Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
- Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
- Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas
- Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Support the definition and execution of inspection readiness activities including support of site self-inspections in GQA
- Lead project initiatives needed in support of the project and Quality function
- Resolve or escalate any compliance issues to the project, site, and Quality Management
- Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
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 with C&Q / Verification and Validation oversight including automation and computer systems validation
Additional Preferences: - Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
- ASQ Certified
- Computer System Quality Assurance experience
- 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 lab equipment delivery and qualification
- Previous experience with management of utilities, facilities, maintenance, and warehouse logistics
- Previous experience with Manufacturing Execution Systems.
- Previous use of KNEAT - or other electronic validation software
- 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 onsite
- During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities
- Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly ) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ...@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly