GDP QA Lead – Upstream Supply Chain

Biopharma Careers; Santa Fe; Híbrido; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Careers | Astellas

Descripción de la vacante

Astellas Global Capability Centre in Mexico City (Santa Fe) seeks a QA professional to oversee US GDP compliance for storage and distribution in upstream supply chain, ensuring GMP/GDP adherence and effective quality systems.

You will collaborate with SCM, 3PLs, and other QA teams, manage nonconformances in TrackWise, support change control, and help drive continuous improvement across our global distribution network.

Formación

• Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree
• Track record of demonstrable and relevant minimum 3 years’ experience within QA, specifically GMP/GDP areas.
• Good understanding of establishing and maintaining (GxP) Quality Management Systems.
• Fluent in business English language (written, verbal, presentation, facilitation)
• Ability to represent the company to external stakeholders.
• Ability to apply industry knowledge and interpretation to anticipate global impact and contribute ideas for strategies and levels of management.
• Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.
• Can develop / execute quality strategies with management guidance.
• Makes decisions for the department in their area of quality expertise with management oversight.

Responsabilidades

• Supports the maintenance and enhancement of the global Astellas GDP QA Quality Management System (QMS) related activities through cross functional team working, specifically self-inspection, KPI monitoring and quality management review processes.
• Supports with US upstream supply chain drug substance, drug product, other materials release activities based on risk through Usage Decision in SAP S/4 in collaboration with SCM and 3PLs.
• Ensures timely documentation of GDP related nonconformances in TrackWise digital with root cause identification and actions for prevention as well as appropriate affected batch disposition based on quality and safety perspective.
• Assesses and approves GDP related changes in TrackWise digital.
• Reviews and approves transportation study documents prepared for new product launch and GDP relevant changes.
• Quality oversight of contracted 3PLs and Freight Forwarders to ensure their quality management system is maintained and enhanced through nonconformance/CAPA management, Business Review Meeting, Auditing, Quality Agreement maintenance and periodical GDP Risk Assessment.

Conocimientos

English proficiency

GxP knowledge

Stakeholder communication

Quality strategy execution

TrackWise knowledge

Educación

BA/BS in Pharmacy/Medical or Biomedical/Life Sciences

Advanced professional degree

Herramientas

TrackWise

Veeva

SAP

Descripción del empleo

Astellas Global Capability Centre in Mexico City (Santa Fe) seeks a QA professional to oversee US GDP compliance for storage and distribution in upstream supply chain, ensuring GMP/GDP adherence and effective quality systems.

You will collaborate with SCM, 3PLs, and other QA teams, manage nonconformances in TrackWise, support change control, and help drive continuous improvement across our global distribution network.