GDP QA Lead – US Distribution & Compliance

Astellas Pharma; Ciudad de México; Híbrido; MXN 700.000 - 1.100.000; Jornada completa

Descripción de la vacante

Astellas Pharma is seeking a GDP QA Oversight professional based in Mexico City, hybrid work setup. The role focuses on GDP compliance for US distribution, quality systems management, and collaboration with 3PLs and internal stakeholders across the Americas.

The position requires extensive QA experience in pharma, strong cGMP/GDP knowledge, and leadership skills to drive quality initiatives and regulatory readiness within a global context.

Formación

• 8+ years in pharmaceutical industry with QA focus.
• Strong knowledge of cGMP/GDP and related regulations.
• Experience implementing GDP, GMP and Quality Management Systems.

Responsabilidades

• Perform GDP QA oversight for storage and distribution of commercial products in the US.
• Manage quality systems and compliance for shipments, deviations, CAPA and risk management.
• Serve as liaison with 3PLs, suppliers and cross-functional teams across the Americas and global affiliates.

Conocimientos

Quality Assurance

GxP knowledge

Leadership

Communication

Stakeholder management

Educación

BA/BS in Life Sciences

Herramientas

Trackwise

Veeva

SAP

Descripción del empleo

Astellas Pharma is seeking a GDP QA Oversight professional based in Mexico City, hybrid work setup. The role focuses on GDP compliance for US distribution, quality systems management, and collaboration with 3PLs and internal stakeholders across the Americas.

The position requires extensive QA experience in pharma, strong cGMP/GDP knowledge, and leadership skills to drive quality initiatives and regulatory readiness within a global context.