GLP Vendor QA Lead - Nonclinical Compliance & Oversight

CSL; Holly Springs (NC); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

CSL is seeking a GLP Vendor Oversight and QA Lead in Holly Springs, NC to ensure external partners meet GLP requirements and data integrity standards. You will own vendor governance, qualification, quality agreements, risk-based monitoring, and CAPA closure across CROs and test facilities.

The role requires leading inspections, guiding quality systems, and maintaining regulatory knowledge across GLP/GCP/GMP frameworks.

Formación

• 3+ years of GxP quality experience with vendor/CRO oversight.
• Experience auditing GLP/GCP/GMP environments.
• Strong communication and negotiation skills.

Responsabilidades

• Oversee vendor lifecycle from due diligence to CAPA closure.
• Plan, conduct, and grade vendor audits and inspections.
• Ensure GLP/GCP/GMP, OECD GLP, and data integrity compliance.
• Lead risk assessments and set oversight frequency.
• Collaborate with global cross-functional teams including Legal and IT.

Conocimientos

GxP quality

vendor oversight

auditing

regulatory knowledge

communication skills

risk assessment

Educación

Bachelor's degree in a scientific discipline

Herramientas

FMEA

Descripción del empleo

CSL is seeking a GLP Vendor Oversight and QA Lead in Holly Springs, NC to ensure external partners meet GLP requirements and data integrity standards. You will own vendor governance, qualification, quality agreements, risk-based monitoring, and CAPA closure across CROs and test facilities.

The role requires leading inspections, guiding quality systems, and maintaining regulatory knowledge across GLP/GCP/GMP frameworks.