Associate Director - QA IAPI
Eli Lilly and Company
2 hours ago
Remote friendly (Indianapolis, IN)
United States
Operations
Responsibilities:
- Manage QA personnel activities supporting oversight of Insulin API manufactured within the Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site.
- Oversee department performance, resolution of quality issues, and regulatory compliance; ensure product/result quality and customer service.
- Drive inspection readiness by developing/maintaining inspection & audit-support processes; prepare individuals for interactions with inspectors/auditors; interface with regulators/customers/external stakeholders.
- Conduct performance management and development of QA staff; provide coaching/feedback.
- Partner across QA and functional disciplines to implement site continuous improvements, site business plan objectives, and GMP Quality Plan objectives.
- Use HR tools for staffing and talent management (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning, Staffing).
- Participate in organizational planning; provide input into business plan and ensure conformance to department budget.
- Maintain and improve quality systems; review/approve deviations, procedures, protocols, and change controls focused on improving manufacturing/business processes.
- Participate in self-assessments and regulatory agency inspections.
- Ensure internal/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 (procedures, forms, job aids, job descriptions).
- Oversee review of changes to Global Quality Standards and ensure local implementation; network with other sites on quality systems.
Basic Qualifications:
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, Engineering, or related).
- 5+ years’ experience in a pharmaceutical manufacturing environment in TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, or Procurement.
- Authorized to work in the U.S. full-time; no visa sponsorship/support.
Additional Skills/Preferences:
- Experience in Manufacturing, QC, QA, Technical Services, Engineering, or Regulatory Affairs.
- Interpersonal/networking skills; ability to organize/prioritize multiple tasks.
- Strong problem-solving/analytical thinking with attention to detail; understanding of computer applications.
- Strong written/verbal communication; ability to influence/lead diverse groups.
- Understanding of statistical tools and analysis; previous supervisory/people leadership experience.
- Project management skills; strategic thinking; flexibility.
Additional Information:
- Minimal travel (<10%); some off-shift (night/weekend) work may be required.
- Onsite role; able to work from home four days per month.
- PPE required when entering manufacturing/lab areas; must carry a work mobile for 24/7 operations.
- Experience with Syncade, Veeva, Tulip, Delta V; experience with Copilot, Calude, etc.
Benefits (if eligible):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., employee assistance, fitness, clubs/activities).
- Manage QA personnel activities supporting oversight of Insulin API manufactured within the Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site.
- Oversee department performance, resolution of quality issues, and regulatory compliance; ensure product/result quality and customer service.
- Drive inspection readiness by developing/maintaining inspection & audit-support processes; prepare individuals for interactions with inspectors/auditors; interface with regulators/customers/external stakeholders.
- Conduct performance management and development of QA staff; provide coaching/feedback.
- Partner across QA and functional disciplines to implement site continuous improvements, site business plan objectives, and GMP Quality Plan objectives.
- Use HR tools for staffing and talent management (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning, Staffing).
- Participate in organizational planning; provide input into business plan and ensure conformance to department budget.
- Maintain and improve quality systems; review/approve deviations, procedures, protocols, and change controls focused on improving manufacturing/business processes.
- Participate in self-assessments and regulatory agency inspections.
- Ensure internal/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 (procedures, forms, job aids, job descriptions).
- Oversee review of changes to Global Quality Standards and ensure local implementation; network with other sites on quality systems.
Basic Qualifications:
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, Engineering, or related).
- 5+ years’ experience in a pharmaceutical manufacturing environment in TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, or Procurement.
- Authorized to work in the U.S. full-time; no visa sponsorship/support.
Additional Skills/Preferences:
- Experience in Manufacturing, QC, QA, Technical Services, Engineering, or Regulatory Affairs.
- Interpersonal/networking skills; ability to organize/prioritize multiple tasks.
- Strong problem-solving/analytical thinking with attention to detail; understanding of computer applications.
- Strong written/verbal communication; ability to influence/lead diverse groups.
- Understanding of statistical tools and analysis; previous supervisory/people leadership experience.
- Project management skills; strategic thinking; flexibility.
Additional Information:
- Minimal travel (<10%); some off-shift (night/weekend) work may be required.
- Onsite role; able to work from home four days per month.
- PPE required when entering manufacturing/lab areas; must carry a work mobile for 24/7 operations.
- Experience with Syncade, Veeva, Tulip, Delta V; experience with Copilot, Calude, etc.
Benefits (if eligible):
- Company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., employee assistance, fitness, clubs/activities).