Commercial Quality Senior Specialist, Poland

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Job Description

ROLE OVERVIEW

Acting as a Commercial Quality 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 aflexible hybrid work modelwith regular in-person collaboration: your in-person time will besplit 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 patients 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 in the LOC Poland for new or emerging regulations.

• Local GxP training administrator for LOC Poland.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:

• Pharmacy masters degree

• 5 years on job experience in Pharmaceutical company in QA environment.

• Experience and proven track record in quality assurance and deep understanding of EU and local laws regulations and Industry codes related to QA.

• Experience of working in a matrix management environment.

• Ability to lead by influence and conflict management.

• Fluent in written and spoken English and Polish.

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the job.

Employees may be eligible for a comprehensive range of benefits and incentives:

• short-term incentives

• Sport cards

• privatemedicalcare subscription

• group life and accidental death insurance

• participation in Employee Capital plans (PPK)

• social foundbenefits

• Well-being benefits and others

Pracownicy mogą być uprawnieni do szerokiego zakresu świadczeńi benefitów:

• system bonusowy

• karty sportowe

• opieka medyczna

• grupowe ubezpieczenie NŻ I NW

• udział w pracowniczych planach kapitałowych (PPK)

• benefity z ZFSS

• well-beingowe benefity oraz inne

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Worker Sub-Type

Time Type