GDP QA Lead – Global Supply Quality & Compliance

Biopharma Careers; Santa Fe; Híbrido; MXN 1.000.000 - 1.800.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Astellas Mexico City seeks a seasoned QA professional to oversee GDP compliance for the storage and distribution of commercial products, ensuring GMP/GDP standards across the supply chain and with third-party logistics providers. You will lead quality systems, drive risk-based QA activities, and liaise with global affiliates in the Americas, EU and Japan.

Fluent English and Spanish are required, with a proven track record in QA leadership and supplier oversight.

Formación

• BA/BS in a pharmaceutical field with 8+ years of pharma/QA experience.
• 5+ years of QA experience and strong GDP/GMP knowledge.
• Experience implementing GDP, GMP and Quality Management Systems.
• Proven ability to coach and lead teams across functions.
• Fluent in English and Spanish, with excellent written and verbal communication.

Responsabilidades

• Oversee GDP guidelines for distribution of medicines in the US.
• Maintain and improve quality systems for GDP, CAPA, Change Control, audits and supplier evaluation.
• Collaborate with SCM and 3PL partners to ensure GMP/GDP compliance and quality risk management.
• Serve as a Quality Ambassador and liaison with global affiliates (Americas, EU, Japan).
• Provide leadership and coaching to QA teams; manage department resources.

Conocimientos

GDP knowledge

Quality leadership

Regulatory liaison

cGMP/GDP compliance

Risk management

Excellent communication

Cross-functional collaboration

Fluent English & Spanish

Educación

BA/BS in Pharmacy/Science

Herramientas

Trackwise

Veeva

SAP

MS Office

Descripción del empleo

Astellas Mexico City seeks a seasoned QA professional to oversee GDP compliance for the storage and distribution of commercial products, ensuring GMP/GDP standards across the supply chain and with third-party logistics providers. You will lead quality systems, drive risk-based QA activities, and liaise with global affiliates in the Americas, EU and Japan.

Fluent English and Spanish are required, with a proven track record in QA leadership and supplier oversight.