Sr. Director - API Manufacturing Quality Assurance

Sr. Director – API Manufacturing Quality Assurance

Position at Lilly, a global healthcare leader headquartered in Indianapolis, Indiana.

Lilly is constructing an advanced manufacturing facility for the production of API molecules. This greenfield site will provide APIs for current and future products, including new modalities. The Senior Director – QA will lead the organization, facility, and culture to enable successful startup into GMP manufacturing operations.

• 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 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. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at  Lilly is a proud 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 base salary range is $151,500 – $222,200. Full‑time employees are eligible for a company bonus and a comprehensive benefit program that includes a 401(k) match, pension, vacation benefits, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, dependents, and wellness programs.