GLP/GCLP Compliance Expert – Vaccine R&D

Sanofi; Northern (KY); Hybrid; USD 113,000 - 164,000; Full time

Job summary

Sanofi is seeking a GLP and GCLP Compliance Expert to support nonclinical GLP/GCLP activities across R&D Vaccines. You will lead the GLP/GCLP quality program, oversee audit activities, and ensure data integrity in clinical laboratory operations while interacting with internal and external partners across geographies.

The role requires a Bachelor's in Life Sciences or Pharmacy with 3+ years in GLP/GCLP compliance, plus travel (~30%). Masters/PhD preferred.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related discipline.
• 3+ years of GLP/GCLP compliance experience in pharma/biotech R&D.
• Strong knowledge of FDA, EMA, OECD, and ICH regulations.
• 3+ years leading audits and managing external partners.
• Willingness to travel internationally (~30%).
• Masters or PhD preferred.

Responsibilities

• GLP: Partner with R&D to embed GLP principles across the test item lifecycle and oversee GLP activities.
• GCLP: Lead development and implementation of a GCLP-aligned QMS for clinical endpoints and support lab oversight.
• External Partner Oversight: Audit CROs/labs, manage CAPA, and act as primary interface with external partners.
• Global Leadership: Train staff on GLP/GCLP, collaborate across functions and geographies, and represent the company in regulatory contexts.

Skills

GLP/GCLP compliance

Audits & external partners

Cross-cultural communication

Autonomy & strategic thinking

Willingness to travel

Education

Bachelor's degree in Life Sciences/Pharmacy

Masters or PhD (preferred)

Job description

Sanofi is seeking a GLP and GCLP Compliance Expert to support nonclinical GLP/GCLP activities across R&D Vaccines. You will lead the GLP/GCLP quality program, oversee audit activities, and ensure data integrity in clinical laboratory operations while interacting with internal and external partners across geographies.

The role requires a Bachelor's in Life Sciences or Pharmacy with 3+ years in GLP/GCLP compliance, plus travel (~30%). Masters/PhD preferred.