Manager, Quality Document Management (Warsaw, PL, 00-844)

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.

Working Environment and Location

This is a perma nent 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

Integrity

Innovation

Impact

One Astellas

Accountability

Courage

Sense of Urgency

Outcome Focus

Benefits

Careers | Astellas

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.

#LI-Warsaw

#LI-Hybrid

#LI-JU1

]]>