About this role
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 behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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 & Scope
- Provide EMEA GDP Quality Assurance oversight for the storage, transportation, and distribution of pharmaceutical products, ensuring compliance with regulatory requirements and Astellas quality standards.
- Partner with Supply Chain, Logistics, and external service providers to proactively manage quality risks and maintain an effective GDP Quality Management System.
- Drive continuous improvement, quality excellence, and supplier oversight across the upstream pharmaceutical supply chain.
Role and Responsibilities
- Provide GDP QA oversight for pharmaceutical storage, transportation, distribution, and third-party logistics (3PL) activities across EMEA.
- Lead and support investigations related to non-conformances, temperature excursions, product damage, distribution incidents, and other quality events.
- Manage and maintain GDP quality systems, including deviations, CAPA, change control, risk assessments, supplier qualification, and quality reviews.
- Establish, review, and maintain Quality Agreements with logistics providers, warehouses, freight forwarders, and other external partners.
- Perform supplier oversight activities, including audits, evaluations, and ongoing compliance monitoring.
- Collaborate with Supply Chain, Logistics, and global QA teams to ensure effective risk management and regulatory compliance.
- Support GDP inspection readiness, self-inspections, and continuous improvement initiatives.
- Provide expert guidance on GDP requirements, distribution-related quality risks, and product launch activities.
Required Qualifications
- Strong pharmaceutical Quality Assurance experience with significant exposure to Good Distribution Practice (GDP) and Quality Management Systems.
- In-depth understanding of GDP, GMP, quality risk management, investigations, CAPA, change control, and supplier oversight processes.
- Demonstrated experience managing quality issues across pharmaceutical supply chains, including transportation, warehousing, and third-party service providers.
- Proven ability to build credibility and influence stakeholders across Quality, Supply Chain, Logistics, and external partner organizations.
- Strong analytical, problem-solving, decision-making, and risk-assessment capabilities.
- Experience developing and maintaining Quality Agreements and managing supplier quality relationships.
- Excellent communication skills with the ability to navigate challenging discussions and drive alignment on compliance-related decisions.
- Relevant education.
- Fluent written and spoken English.
Preferred Qualifications
- Responsible Person (RP) certification or equivalent GDP-related qualification.
- Experience leading teams, projects, or providing coaching and guidance within a Quality environment.
- Experience supporting regulatory inspections, vendor audits, and interactions with health authorities.
- Knowledge of pharmaceutical serialization, product security, or drug supply chain regulations.
- Familiarity with electronic Quality Management Systems and enterprise platforms such as TrackWise Digital, Veeva, SAP, and Microsoft Office applications.
- Experience operating within international or global pharmaceutical organizations and collaborating across multiple regions.
What awaits you at 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
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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