What are the responsibilities and job description for the API EM Quality Assurance Associate Director position at Jobleads-US?
Job Title: API External Manufacturing (API EM) QA Associate Director
We are a global healthcare leader with operations around the world, working to discover and bring life-changing medicines to those who need them. Our goal is to improve the understanding and management of disease, as well as give back to our communities through philanthropy and volunteerism.
The API External Manufacturing (API EM) Quality Assurance (QA) team plays a crucial role in ensuring that safe, high-quality drug substance is produced at contract manufacturers to meet the needs of patients we serve.
About the Role
The API EM QA Associate Director is responsible for ensuring that API EM operations have robust quality oversight. This includes:
- Quality projects supporting API EM
- The productivity and development of the QA employees
- The quality of large molecule and peptide intermediate products manufactured by Contract Manufacturers (CM)
The Associate Director will oversee the department's performance, resolution of quality issues, and compliance. Key responsibilities include:
- Making decisions regarding the quality of batches and resolution of quality issues
- Leading the API EM QA team and providing coaching/feedback to develop QA employees
- Building working relationships with API EM management, key internal customers/partners, and strengthening CM alliances
- Establishing and improving business processes to provide necessary interface between CMs and Lilly's quality systems
Requirements
To be successful in this role, you will need:
- Prior experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering, and/or Regulatory Affairs
- Understanding of statistical tools and analysis
- Excellent interpersonal skills and networking skills
- BS in a science-related field, engineering, or equivalent experience
- Demonstrated understanding of computer applications
This role requires travel and may involve 24 hour/day operations support. We are committed to diversity and inclusion and welcome applicants from diverse backgrounds.
