Quality Assurance Specialist – Maternity Leave Coverage

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Job Description

OBJECTIVES/PURPOSE

• Responsibilities cover remote quality oversight of local GxP related activities for Local operating company (LOC) Bulgaria and Romania, including in-country distribution quality, local quality surveillance, as applicable.
• Support operational quality tasks, documentation, and process improvements for both countries (and within Eastern Europe cluster, as appointed).
• 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.

ACCOUNTABILITIES

General

Employee is obliged to work in accordance with applicable legislation and Takeda’s internal requirements and processes.

COMMERCIAL QUALITY

• Manage GxP regulated activities to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.
• Support local implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) aligned with local requirements.
• Contribute to development and maintaining GxP related controlled documents in the LOC QMS.
• Support local Gap assessment - 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.
• Support local (Bulgaria and Romania) management of change controls, deviations, CAPA, complaints in collaboration with local stakeholders, primarily supply chain and regulatory affairs.
• Ensure all relevant LOC colleagues performing GxP/quality-related tasks are appropriately trained prior to performing activities.
• Assist with Quality Council reporting and key performance indicators (KPIs) management for both countries according to Takeda Global Quality requirements.
• Support submissions of relevant documentation for plasma products (MIF/OCABR) in LOC Romania/Bulgaria - preparing regulatory notifications for Health Authority, including cover letters; local tracker maintenance in collaboration with LOC RA and supply chain
• Support local Health Authority communication on product quality issues, if needed and when assigned by line manager.
• Support management of inspections, audits, and self-assessments, if needed.
• Collaborate with LOC leaders, Regulatory Affairs, Supply Chain, and cluster QA colleagues to maintain compliance and drive performance, including process improvements/simplification and digital initiatives within Eastern Europe cluster.
• Strengthen Quality Culture at LOC.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Scientific university degree (BSc or MSc) in Pharmacy, Chemistry, Biotechnology or a related scientific field.
• Understanding of EU regulations related to QA.
• On the job experience (1-2 years) in pharmaceutical company in QA and GxP-regulated areas is preferred.
• Experience working in a matrix-managed environment and/or in a remote setting is an advantage.
• Fluent in written and spoken English.

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Good communication skills
• Ability to manage complexity & balance priorities.
• Risk identification, evaluation, and management.
• Appetite for continuous learning, interest in process improvements
• Digital Dexterity - the ability and ambition to embrace existing and emerging technologies to drive better personal and business outcomes.

Leadership Behaviors

• Enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Ability to collaborate locally and cross-functionally, drive change by influence, and think strategically.

ADDITIONAL INFORMATION

• A fixed-term position for maternity leave coverage, with an expected end date of January 2027.
• The position is based in Croatia, with a hybrid working arrangement (office/home-office).
• The role is supported by local QA team to ensure smooth onboarding.
• The successful candidate will work extensively with electronic Quality Management Systems (eQMS) and other digital platforms to support and continuously improve quality processes. The candidate should be willing and curious to learn new systems, adapt quickly to evolving digital solutions, and actively use digital tools in their daily work.

Locations

Zagreb, Croatia

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time