Sr. Director - API Manufacturing Quality Assurance Employer Eli Lilly and Company Location Huntsville, Alabama Start date Sep 7, 2026 View more categories View less categories Discipline Manufacturing & Production , Manufacturing/Mechanical , Quality Required Education Bachelors Degree Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Lilly is currently constructing an advanced manufacturing facility for production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Position Overview The Sr. Director - QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel. Additionally, the Sr. Director - QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements. Key Responsibilities Serve as Site Quality Leader on the Lilly Site Lead Team. Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. Lead the API Quality Team and manage its agenda. Support quality forums (e.g., Deviation and Change Control Boards). Develop and monitor a site Quality Plan and metrics. Coordinate and manage regulatory inspections. Review and approve manufacturing and quality system documents. Ensure adequate QA staffing and provide coaching and development. Use HR tools for performance management, staffing, and succession planning. Contribute to QA business planning and site-wide strategic planning. Basic Requirements Bachelor's degree (STEM degree preferred) 10+ years of pharmaceutical manufacturing quality experience 5+ years of supervision/leadership experience Additional Preferences Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs Proficient in statistical analysis and computer applications Strong interpersonal, communication, and networking skills Ability to influence diverse teams and manage multiple priorities Demonstrated problem-solving and analytical thinking 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800 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. #WeAreLilly Company Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. Company info Location 893 S Delaware St Indianapolis Indiana 46285 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Manager Quality Assurance, Compliance East Greenbush, New York Senior Director, Global Regulatory Strategy, Oncology Cambridge, Massachusetts Senior Manager, Regulatory Affairs South San Francisco