Title:  Manager, Quality Document Management

About Astellas

Astellas’ Global Capability Centres – Overview

Working Environment and Location

• 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 and Scope

• Support QA Document Records Program: Help set up and manage a Quality Assurance (QA) document records program. This involves systematically assessing, reviewing, controlling, distributing, retaining, and archiving records from customers and stakeholders. 
• Manage QA Document Life Cycle: Identify and support processes for managing the lifecycle of QA documents and records. This includes tracking system administration, filing, archiving, and retention. 
• Ensure Regulatory Compliance: Ensure that all documents and their retention meet global regulatory requirements, such as cGMP, GLP, GCP, and electronic records and signatures. 
• Lead QA Improvements: Lead continuous improvement projects for QA documentation processes that may impact multiple departments. 

Role and Responsibilities

• Manage the QA document control program, including document metrics, prioritization, and workflow oversight.
• Maintain the central repository of QA-controlled documents and ensure accurate tracking, storage, and retention. 
• Support document review, approval, distribution, and compliance processes across internal and external stakeholders. 
• Develop and maintain QA document management procedures in line with regulatory and global quality standards. 
• Ensure QA records are organized, accessible, and audit-ready while meeting SOP and regulatory requirements. 
• Identify document management risks, recommend solutions, and support continuous process improvements. 
• Collaborate cross-functionally to drive timely review, approval, and implementation of quality documents. 
• Generate and analyze quality metrics to support QA performance monitoring and management review. 
• Deliver training on document control procedures, quality systems, and QA processes. 
• Support the implementation and enhancement of quality systems, documentation standards, and regional quality initiatives. 

Essential Qualifications

• Experience in Quality Assurance/document control within a regulated GxP environment (Pharma, Biopharma, Medical Devices, or similar).
• Strong knowledge of GxP regulations, document management, record retention, and compliance requirements.
• Hands-on experience with electronic document management systems, ideally Veeva Vault Quality/Documentation.
• Strong stakeholder management and communication skills with experience working across global teams.
• University degree.
• Fluency in English.

Preferred Qualifications

• Experience creating, reviewing, or maintaining SOPs and other controlled quality documents.
• Previous involvement in training colleagues, supporting process improvements, or contributing to quality system enhancements would be welcomed.

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 Organisational Values and Behaviours

Benefits

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