Quality Assurance, US Affiliate (3 positions)

Astellas Pharma; Santa Fe; Híbrido; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Astellas is seeking an experienced Affiliate QA professional for our Global Capability Centre in Mexico City (Santa Fe). The role focuses on independent QA activities within GDP/GMP frameworks and requires on-site work in a hybrid setup.

You will support inspections, coordinate with global project teams, and uphold our QA records and quality culture. Fluency in English and Spanish, plus a science/health degree and 4+ years in pharma QA, are essential.

Formación

• University degree in a science/health-related subject.
• Minimum 4 years of relevant experience in a pharmaceutical QA role.
• Significant experience with GDP, GMP and Quality Management Systems.
• Fluency in English and Spanish.
• Strong organizational, coordination, diplomatic, negotiation, presentation and communications skills.

Responsabilidades

• Performs GDP QA activities per QMS and identifies improvements.
• Supports inspection management for licenses and recalls.
• Represents Affiliate QA in local/global project teams (e.g., product launches).
• Escalates to Affiliate Head on complex/urgent QA activities.
• Performs final QA acceptance of QA records (excluding product returns).
• Acts as a role model for the Quality Culture in the affiliate.

Conocimientos

GDP/GMP knowledge

Quality Management Systems

English fluency

Spanish fluency

Communication skills

QA oversight

Educación

Science/health degree

Herramientas

Trackwise (Digital)

Veeva

SAP

Descripción del empleo

Careers | Astellas

Job description:

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Working Environment and Location

This position is based in Mexico City (Santa Fe area) and will require on-site work in a hybrid set up.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

Independently completing standard quality assurance activities as well as complex and non-standard quality assurance activities in the affiliate.

Role and Responsibilities

• Performs and records all activities that are governed by Good Distribution Practise Guidelines (GDP Guidelines) as defined in the (global) Quality Management System (for example on QA oversight of Product Storage and Distribution, nonconformance management, product complaint handling change control, supplier management and annual product review) and identifies and implements improvements to the QMS to correct inefficiencies and non-conformances
• As needed, supports with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls.
• Represents Affiliate QA in complex local and global project teams, such as product launches.
• Escalates to Affiliate Head any complex and urgent QA activities such as potential recalls, significant quality issues and urgent changes.
• As needed, performs final QA acceptance of all QA records (apart from product returns)
• Acts as a role model for the Quality Culture in the affiliate.

Essential Qualifications

• (University) degree in a science/health-related subject.
• Minimum 4 years relevant experience in a comparable role in the pharmaceutical industry.
• Significant experience of implementation and understanding of GDP, GMP and Quality Management Systems
• Fluency in written and spoken English and Spanish
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills.

Preferred Qualifications

• Experience with Trackwise (Digital), Veeva and SAP systems
• Experience in supporting regulatory interfaces such as inspections and audits

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champion

Our Organizational Values and Behaviors

Values: Integrity, Innovation and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.