Job Description
**Job Summary:** Lilly's API External Manufacturing (API EM) team seeks a Quality Assurance Associate Director to oversee quality oversight, manage quality projects, and ensure compliance with Lilly quality standards and CGMPs.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. Our employees 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.
The Quality Assurance Associate Director will be responsible for:
- Ensuring that API EM operations have robust quality oversight
- Managing quality projects supporting API EM and the productivity and development of the QA employees
- Overseeing the quality of large molecule and peptide intermediate products manufactured by the Contract Manufacturers (CM)
- Ensuring compliance with Lilly quality standards and CGMPs
- Resolving quality issues and overseeing department performance
The ideal candidate will have:
- Demonstrated knowledge of CGMPs
- Prior experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering, and/or Regulatory Affairs
- Strong written and verbal communications skills
- Strong attention to detail
- Understanding of statistical tools and analysis
- Excellent interpersonal and networking skills
- Ability to organize and prioritize multiple tasks
- Demonstrated strong problem-solving and analytical thinking skills
- Ability to influence diverse groups
Preferred qualifications include experience in monoclonal antibodies, microbially expressed products, and/or peptide intermediates, as well as previous experience supervising/leading people.