Title:  Quality Assurance, GDP

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. 

Are you driven to make a real difference in the lives of patients? 

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

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

This position is responsible for US Good Distribution Practice (GDP) QA oversight of Storage and Distribution activities related to upstream supply chain for drug substance, drug product, and commercial products. Provides support for daily activities between Astellas stakeholders including Supply Chain Management (SCM) group other QA teams and external third-party logistics (3PL) providers to ensure effective quality systems that meet Good Manufacturing Practice (GMP), GDP, and established Astellas requirements.

Role and Responsibilities

• 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.

Essential Qualifications

• 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.

Preferred Qualifications

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

Benefits

Careers | Astellas

Why Astellas

• We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. 
• People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Learn more at Astellas.com