Senior Advisor, Global Quality Auditing (GxP)

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 211,000; Full time

Job summary

Lilly in Indianapolis seeks a Senior Advisor in Global Quality Auditing to lead audits across pharmaceutical development, non-clinical and clinical research, and pharmacovigilance. You will drive compliance with GxP standards and regulatory expectations, contributing to quality through technical guidance and strategic input.

The role requires planning and leading complex audits, reviewing GxP metrics, and mentoring the team to improve quality processes.

Qualifications

• Bachelor’s degree in physical or biological sciences, engineering or a related scientific/technical discipline.

Responsibilities

• Audits and assessments of development, non-clinical and clinical research, business development, product commercialization, and pharmacovigilance to ensure GxP compliance.

Skills

GxP auditing

Process thinking

Project management

Regulatory interpretation

Communication

Teamwork

Data analysis

Education

Bachelor’s degree in physical or biological sciences, engineering or a related scientific/technical discipline

Job description

Lilly in Indianapolis seeks a Senior Advisor in Global Quality Auditing to lead audits across pharmaceutical development, non-clinical and clinical research, and pharmacovigilance. You will drive compliance with GxP standards and regulatory expectations, contributing to quality through technical guidance and strategic input.

The role requires planning and leading complex audits, reviewing GxP metrics, and mentoring the team to improve quality processes.