Title:  Lead, 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 commercial products.  Oversees and defines quality expectations and provides support to the Supply Chain Management (SCM) group and external Third-Party Logistics (3PL) providers to ensure effective quality systems that meet Good Manufacturing Practice (GMP), GDP, and Astellas requirements for upstream supply chain related activities (Plant/Contract Manufacturing Organization-to-3PL or 3PL-to-Astellas affiliate).

Role and Responsibilities

• Performs and records all activities that are governed by GDP Guidelines for medicinal products and/or applicable local legislation, which outline the provisions for distribution of medicines in the US.
• Oversees the quality systems that have been established to maintain compliance of the Astellas’ drug substance, bulk, and drug product shipments and storage. 
• Anticipates and prioritizes QA activities related to commercial products based on risk.
• Serves as the main point of contact between Astellas and centrally managed third party logistics providers for quality issues and has oversight of Supplier Evaluation Programs, Quality Agreements, Change Management and Quality Risk Management. This position communicates potential risks to upper management for appropriate action in collaboration with colleagues and affiliates within the Americas region as well as global counterparts in EU and Japan.
• Manages or supports the following quality systems for GDP: Deviation Management (including CAPA), Change Control, SQI Management, Risk Evaluation Committee, Audits, Supplier Evaluation, Quality Business Review Meetings and Regulatory Intelligence.
• Acts as a Quality Ambassador focusing and influencing third parties to comply with Astellas quality standards, policies, and industry GDP requirements.
• Appointed Delegate for Head, Supply Chain QA for US GDP matters.

Essential Qualifications

• BA / BS with minimum 8 years of pharmaceutical industry experience, minimum 5 years of QA experience.
• In-depth knowledge of cGMP/GDP and other regulations as required with a broad knowledge of quality principles and industry trends.
• Significant experience of implementation and understanding of GDP, GMP and Quality Management Systems.
• Effective written, oral communication and interpersonal skills as well as facilitation skills with an ability to effectively work across the Astellas groups and external stakeholders.
• Demonstrates strong leadership, along with the necessary influencing and negotiating skills to perform effectively within this role.
• Demonstrated experience for coaching individuals and teams.
• 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.
• Must be a self-starter, detailed-oriented, analytical mindset, proactive and can manage department resources to achieve desired outputs. 
• Demonstrated experience in developing/executing quality strategies with a pragmatic approach to decision-making.
• Fluent in written and verbal business English and Spanish.

Preferred Qualifications

• Minimum of 3 years of managerial experience.
• Experience in supporting regulatory interfaces such as GDP inspections and audits. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
• Knowledge of PDMA regulations desired.
• Proficient with Trackwise (Digital), Veeva, SAP systems and MS Excel, WORD, PowerPoint.

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, champions your development, and empowers you to pursue your passions.

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.