Global Medicines Quality Leader & HEOR Quality Advisor

Regulatory Jobs; Indianapolis (IN); Sur place; USD 66 000 - 119 000; Plein temps

Avantages offerts par ce poste

401(k) match

Pension

Vacation benefits

Medical/Dental/Vision benefits

Flexible benefits

Life insurance

Time off & leave

Well-being program

Résumé du poste

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Quality role focused on HEOR and global quality assurance. The position emphasizes interpreting regulations, ensuring compliance, and leading CAPA and inspection readiness across regulatory and cross-functional teams.

Ideal candidates will have a strong background in GxP, project management, and English communication, with 5+ years in quality or related pharmaceutical research.

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.

Responsabilités

• Interprets regulations and guidelines, defines quality direction, and provides direct input into quality systems to meet internal and external expectations.
• Applies quality expectations specific to RWE methodology and pre-specification of analyses, protocol approval, and registration prior to conduct.
• Performs ongoing risk assessment to identify performance and compliance gaps against current regulations, company standards, and internal procedures.

Connaissances

Quality Assurance

GxP Knowledge

Project Management

English Proficiency

Formation

Bachelor's Degree in Science/Tech or related field

Description du poste

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Quality role focused on HEOR and global quality assurance. The position emphasizes interpreting regulations, ensuring compliance, and leading CAPA and inspection readiness across regulatory and cross-functional teams.

Ideal candidates will have a strong background in GxP, project management, and English communication, with 5+ years in quality or related pharmaceutical research.