QA Document Control Manager – Hybrid (GxP)

Biopharma Careers; Warszawa; Hybrid; PLN 190,000 - 280,000; Full time

Benefits offered by this job

Hybrid work model

Global collaboration with life science

Job summary

Astellas is seeking a QA Document Control specialist to support the Quality Assurance program at our Global Capability Centre in Warsaw, Poland, with hybrid working and office presence as needed.

You will manage document lifecycle, ensure regulatory compliance (GxP, cGMP, GLP, GCP), maintain the central repository, and coordinate across global teams. Fluency in English and a university degree are essential.

Qualifications

• Experience in Quality Assurance/document control within a regulated GxP environment.
• Strong knowledge of GxP regulations, document management, 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.
• Fluency in English.

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.

Skills

Quality Assurance

GxP Regulations

Document Management

Stakeholder Management

English Fluency

Education

University degree

Tools

Veeva Vault Quality/Documentation

Job description

Astellas is seeking a QA Document Control specialist to support the Quality Assurance program at our Global Capability Centre in Warsaw, Poland, with hybrid working and office presence as needed.

You will manage document lifecycle, ensure regulatory compliance (GxP, cGMP, GLP, GCP), maintain the central repository, and coordinate across global teams. Fluency in English and a university degree are essential.