Lilly Associate Director, Quality Assurance in Lebanon, Indiana
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 35,000 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.
For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Eli Lilly and Company is breaking ground on a new facility in Lebanon, Indiana, with primary focus on the manufacture of Advanced Therapeutic Medicinal Products (ATMPs) such as gene therapies. The Associate Director, Quality Assurance, for this site (LP2) is the management representative who, irrespective of other responsibilities, has the responsibility for establishment, monitoring and continuous improvement of the site's Quality Management System (QMS). The individual in this role ensures that processes needed for execution of the quality management system are documented and monitored for effectiveness. The QMS will be flexible in nature to allow for all production activities from Product Research and Development (PR&D) through Commercial operations including cell/virus banking, drug substance, drug product and final shipping controls. The LP2 site will be the first Lilly manufacturing facility operating within the ATMP framework. This role is responsible for QA technical oversight including document approvals (e.g., Commissioning and Qualification Packages, procedures) and cross-functional decision making. As the project progresses, this role will transition to site-based leadership, responsible for the staffing, training, and leadership of the quality assurance group. The Associate Director, Quality Assurance, supports the design and development of key operational oversight, site compliance and inspectional readiness systems and procedures that support the site validation and registration. After startup, the Associate Director will continue to foster a strong quality culture and cultivate operational excellence through demonstrated leadership.
The Associate Director, Quality Assurance, will establish, monitor, and improve the Quality Management System at Lilly's LP2 pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.
Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site Quality programs
Serve as technical resource to review and approve technical documents (e.g., user requirements, test cases, validation protocols, procedures)
Support the development of the overall site operational readiness plan
Build a diverse and capable quality assurance organization linked to the Lilly global organization in support of creating and implementing the site Quality Compliance Programs, supporting qualification, validation, and routine production
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Network with global and other applicable networks to understand best practices, share knowledge
Participate in tactical and strategic business planning
Work cross-functionally across all areas of the site for coordination, planning, and execution of activities
Coordinate site regulatory strategy with the global regulatory group
Plan and support execution of site regulatory agency inspections and site readiness
Coordinate the creation and execution of the site Quality Plan
Plan and execute the site self-assessment program
Ensure data integrity by design
Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
Experience in gene therapies
Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, ATMP)
Previous experience directly supporting pharmaceutical operations (e.g., drug substance, parenteral drug product), preference for support with cell or gene therapy
Previous regulatory inspection readiness and inspection execution experience
Previous facility or area start up experience, including equipment and process validation support
Excellent interpersonal, written, and oral communication skills
Strong technical aptitude and ability to train and mentor others
Demonstrated technical writing skills
Demonstrated problem-solving and decision-making skills
CQM or CQE certification from the American Society for Quality (ASQ)
Project management experience
Previous Computer System Quality Assurance experience
Ability to work 8-hour days – Monday through Friday, onsite
Ability to work overtime as required
Ability to travel 10-25% or potentially relocate during the project phase to support the design and staffing of the facility
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 ( LillyRecruitingCompliance@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.
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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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!