Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company
Summary
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.
Job description
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
Requirements
- 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
- 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
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.