Sr. Director - API Manufacturing Quality Assurance

Join to apply for the Sr. Director - API Manufacturing Quality Assurance role at Eli Lilly and Company
. 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, dedicated to discovering and delivering life‑changing medicines and improving disease management worldwide.

Lilly is constructing an advanced manufacturing facility for the production of API molecules intended to provide APIs for current and future products, including new modalities. This facility is a greenfield site, and the successful candidate will join the leadership team to build the organization, the facility, and the culture for successful GMP manufacturing operations. 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, and 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.

• 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.

• Bachelor's degree (STEM degree preferred)
• 10+ years of pharmaceutical manufacturing quality experience
• 5+ years of supervision/leadership experience

• Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs
• Proficiency 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 () for further assistance. 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 – $222,200. Full‑time equivalent employees are also eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, 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.