Commercial QA Senior Specialist, Poland

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Job Description

ROLE OVERVIEW

Acting as a QA Senior Specialist, your main responsibility will be to support the Poland LOC in delivering high-quality, compliant products to patients by providing strong GDP and GxP quality oversight and partnering closely with local and global stakeholders.
You will work across key quality processes, contribute to continuous improvement, and help ensure Takeda meets both internal standards and Polish regulatory requirements.
We offer a flexible hybrid work model with regular in-person collaboration: your in-person time will be split between our Warsaw office and our warehouse in Kopytów, with the remaining time worked flexibly in line with team needs and business priorities.

OBJECTIVES/PURPOSE

• Support the achievement of business success with regards to GDP and quality related activities in the LOC as a Responsible Person (RP) deputy for Poland LOC. Maintain the Wholesale Distribution Authorization of Takeda for medicinal products and medical devices according to the Polish regulations and internal company requirements. Supporting oversight processes for controlled products to ensure compliance with legal regulations.

• Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, national release process for plasma and immunological products, PQR quality oversight, and in-country medical device activities.

• Work in collaboration with other GxP and non-GxP functions focusing on patient’s needs, regulatory compliance, as well as internal standards and SOPs and continuous improvement.

• Key stakeholders support in the Poland LOC on quality matters and initiatives. Contribute to the achievement of business success.

• As Responsible Person (RP) deputy, decides independently from the management about the release, the block, or recall of batches. Take other QA relevant decisions independently, as needed.

ACCOUNTABILITIES ( primary duties and responsibilities )

• Manage GxP regulated activities in Poland LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.

• Support the oversight of maintaining R&D suppliers as part of the qualification and evaluation process for these suppliers- in the scope of conducting an audit and post-audit activities.

• Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.

• Support implementation of Takeda QMS and ensuring the ongoing compliance to the quality standards and procedures at the LOC both for GDP and R&D activities. These include but are not limited to: change control, deviation, CAPA management, document management, complaint handling, vendor audits, internal audits & self-inspections etc as well as KPI adherence oversight

• Develop and maintain GxP related controlled documents in the LOC Quality Management System.

• Ensure that LOC QMS is implemented and aligned with the needs of the organization, including a contribution for development and review of QMS documents. Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions, such as consultation with subject matter experts and creation/update of processes and applicable training.

• Supports an effective GDP implementation at Poland LOC including warehouse and distribution quality assurance oversight.

• Support management of inspections, audits, and self-assessments, and ensure LOC audit/inspection readiness.

• Support local Health Authority communication on product quality issues, if needed and when assigned by line manager.

• Support the preparation and maintain oversight of internal and external contracts and quality agreements on LOC level.

• Support regulatory surveillance & intelligence i