Global Medicines Quality Strategy Lead

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k) plan

Pension

Medical plan

Dental/vision benefits

Vacation benefits

Job summary

Lilly in Indianapolis seeks a Quality Assurance professional specializing in HEOR and post-authorization studies. You will interpret regulations, define quality direction, and lead CAPA, risk assessments, and audits across HEOR and GQA.

The role collaborates with Clinical Development, Global Patient Safety, Regulatory Affairs, and IT to ensure compliance, inspection readiness, and continuous improvement. Strong GxP knowledge and fluent English are essential.

Qualifications

• Bachelor's Degree in a science, technology or medically related field or equivalent relevant work experience.
• At least 5 years' experience in quality, health economics and outcomes research, real world evidence, epidemiology, or a related pharmaceutical research discipline.
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.

Responsibilities

• Interprets regulations and guidelines; defines quality direction; inputs into quality systems for HEOR, RWE, and pharmacovigilance.
• Leads inspection readiness, regulatory inspections, and responses; supports GMQO portfolio audits and improvements.
• Engages leadership to resolve complex issues; drives harmonization of best practices and cross-regional collaboration.
• Manages issues with clear action plans and escalations to management; ensures continuous quality improvements.

Skills

Quality management

CAPA management

Regulatory knowledge

RWE/HEOR

GxP regulations

Project management

English communication

Education

Bachelor's degree in science/tech or related

Job description

Lilly in Indianapolis seeks a Quality Assurance professional specializing in HEOR and post-authorization studies. You will interpret regulations, define quality direction, and lead CAPA, risk assessments, and audits across HEOR and GQA.

The role collaborates with Clinical Development, Global Patient Safety, Regulatory Affairs, and IT to ensure compliance, inspection readiness, and continuous improvement. Strong GxP knowledge and fluent English are essential.