GLP/GCLP Compliance Lead — Global Vaccines

Sanofi; Northern (KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Sanofi is seeking a GLP and GCLP Compliance Expert based in Swiftwater, PA, to globally support GLP and GCLP activities within R&D Vaccines. You will guide study design, oversight, and data integrity across internal and external partners, with international travel and cross-functional collaboration.

The role emphasizes independent operation, quality oversight, and strategic involvement in regulatory compliance across multiple geographies and time zones.

Qualifications

• Minimum 3+ years in GLP/GCLP compliance within pharma/biotech R&D.
• Strong knowledge of FDA, EMA, OECD, ICH frameworks.
• Willingness to travel internationally (~30%).

Responsibilities

• Embed GLP principles across the test item lifecycle.
• Oversee GLP activities and document test items.
• Provide guidance on GLP study design, conduct and reporting.
• Lead the development of a GCLP-aligned QMS for clinical endpoints.
• Support lab selection, qualification, and oversight.
• Ensure data integrity and regulatory compliance in clinical labs.
• Conduct audits of CROs and third parties; manage CAPA.
• Act as primary quality interface with external laboratory partners.

Skills

GLP/GCLP compliance

Audits

Vendor management

Cross-cultural comms

Strategic thinking

Autonomy

Education

Bachelor's degree in Life Sciences, Pharmacy, or related discipline

Job description

Sanofi is seeking a GLP and GCLP Compliance Expert based in Swiftwater, PA, to globally support GLP and GCLP activities within R&D Vaccines. You will guide study design, oversight, and data integrity across internal and external partners, with international travel and cross-functional collaboration.

The role emphasizes independent operation, quality oversight, and strategic involvement in regulatory compliance across multiple geographies and time zones.