Associate Director – QA – LAPI
Eli Lilly and Company
August 12, 2026
On-site
Lebanon, IN
Operations
Associate Director – QA (API Manufacturing Site)
Position Overview
- Partner with the Sr. Director – QA to ensure robust quality oversight across operations.
- Responsible for productivity and development of QA employees, quality of product/results, oversight of manufacturing and support operations, and overall customer service.
- Oversee department performance, resolution of quality issues, and regulatory compliance.
Key Objectives/Deliverables
- Coach/feedback and develop QA employees.
- Use HR tools for talent decisions (e.g., performance management, merit delivery, talent assessment, succession planning, staffing).
- Participate in organizational planning and provide input into business plan; ensure conformance to area budget.
- Maintain and improve quality systems.
- Approve deviations, procedures, protocols, and change controls.
- Develop/maintain inspection and audit processes; prepare staff for auditors/inspectors.
- Participate in self-assessments and regulatory agency inspections.
- Ensure internal and external quality and supply commitments are met.
- Provide quality management oversight for API manufacturing, laboratories, and warehouses.
- Investigate complaints.
- Manage creation/revision/maintenance of cGMP documents.
- Provide oversight/review of changes to Global Quality Standards and ensure local implementation.
- Network with other sites on quality systems.
Basic Requirements
- BS or equivalent in a scientific field or engineering.
- 5+ years in CGMP Manufacturing.
Additional Preferences
- Knowledge of cGMPs.
- Leadership experience in Manufacturing/QC/QA/Technical Services/Engineering/Regulatory Affairs.
- Experience supervising/leading people; strong written/verbal communication; attention to detail; statistical tools/analysis; interpersonal/networking; organize/prioritize; problem solving/analytical thinking; ability to influence diverse groups; computer applications.
Other Information
- Complete Learning Plan for Associate Director – QA – LAPI.
- No certifications required.
- Enter manufacturing/lab areas requiring appropriate PPE; support 24-hour/day operations; some travel may be required.
Position Overview
- Partner with the Sr. Director – QA to ensure robust quality oversight across operations.
- Responsible for productivity and development of QA employees, quality of product/results, oversight of manufacturing and support operations, and overall customer service.
- Oversee department performance, resolution of quality issues, and regulatory compliance.
Key Objectives/Deliverables
- Coach/feedback and develop QA employees.
- Use HR tools for talent decisions (e.g., performance management, merit delivery, talent assessment, succession planning, staffing).
- Participate in organizational planning and provide input into business plan; ensure conformance to area budget.
- Maintain and improve quality systems.
- Approve deviations, procedures, protocols, and change controls.
- Develop/maintain inspection and audit processes; prepare staff for auditors/inspectors.
- Participate in self-assessments and regulatory agency inspections.
- Ensure internal and external quality and supply commitments are met.
- Provide quality management oversight for API manufacturing, laboratories, and warehouses.
- Investigate complaints.
- Manage creation/revision/maintenance of cGMP documents.
- Provide oversight/review of changes to Global Quality Standards and ensure local implementation.
- Network with other sites on quality systems.
Basic Requirements
- BS or equivalent in a scientific field or engineering.
- 5+ years in CGMP Manufacturing.
Additional Preferences
- Knowledge of cGMPs.
- Leadership experience in Manufacturing/QC/QA/Technical Services/Engineering/Regulatory Affairs.
- Experience supervising/leading people; strong written/verbal communication; attention to detail; statistical tools/analysis; interpersonal/networking; organize/prioritize; problem solving/analytical thinking; ability to influence diverse groups; computer applications.
Other Information
- Complete Learning Plan for Associate Director – QA – LAPI.
- No certifications required.
- Enter manufacturing/lab areas requiring appropriate PPE; support 24-hour/day operations; some travel may be required.