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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 gene therapy 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 Site Compliance Representative has primary responsibility for the establishment, monitoring, and continuous improvement of the site's Quality Management System (QMS). The individual in this role will provide technical leadership for the design and development of key site compliance and inspectional readiness systems and procedures that support implementation of the overall Lilly and site Quality Management Systems. The QA Site Compliance Representative ensures that processes needed for execution of the quality management system are documented and monitored for effectiveness. They will report site QMS performance to senior management and promote awareness of applicable regulatory requirements through management review and other established processes. After startup, the QA Site Compliance Representative will continue to foster a strong quality culture and cultivate operational excellence through support and execution of key site quality programs; regulatory submissions; process oversight/batch release; and site inspection readiness/execution.

Responsibilities:

The Quality Assurance Site Compliance Representative will establish, monitor, and improve the Quality Management System at the LP2 gene therapy manufacturing site in Lebanon, Indiana. Responsibilities include technical leadership as well as project management activities including but not limited to:

• Cross-functional development, implementation, and maintenance of the Quality Management System programs, systems, and procedures in accordance with 21CFR210/211 and applicable Lilly Global Quality Standards for QMS elements including:

• Operational compliance

• Site Quality Manual and Plan

• Deviation, change control, and corrective/preventive action program

• Vendor/material management

• Internal/external audit program

• Batch Release

• Complaints

• Facility, Utility and Maintenance delivery and Asset Qualification Monitoring

• Lead reporting of the performance of the quality systems to management with executive responsibility for review through management review

• Support the development of the overall site operational readiness plan

• Network with global and other parenteral sites to understand best practices, share knowledge

• Work cross-functionally across all areas of the site for coordination, planning, and execution of QMS activities

• Coordinate site regulatory strategy with the global regulatory group

• Plan and support execution of site regulatory agency inspections

• Work with site data integrity resources to ensure data integrity by design

Basic Requirements:

• Bachelor's degree in a science, engineering, pharmaceutical-related field of study

• 5+ years in pharmaceutical-specific QA experience, including leading or working effectively with a cross-functional group

Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, EU MDR, ISO)

• Previous regulatory inspection readiness and inspection execution 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

• Excellent interpersonal, written and oral communication skills

• Strong technical aptitude and ability to train and mentor others

• Demonstrated problem-solving and decision-making skills

• Previous work with combination products or devices with experience with US/EU regulations and notified bodies

• Previous facility or area start up experience

• CQM or CQE certification from the American Society for Quality (ASQ)

• Previous Computer System Quality Assurance experience

Additional Information:

• 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. Once the Lebanon project has further evolved, the position will transition to a Monday-Friday on-site role, with flexibility in special circumstances.

• Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific Lilly Quality System knowledge and/or to acquire current expertise on applicable regulations for gene therapy drug substance and drug product manufacture.

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