Senior Quality Specialist

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Job Description

INTRODUCTION

Takeda’s Local Operating Company (LOC) Portugal operates within the Iberia Multicountry Organization (MCO), covering Portugal and Spain. This role is essential in ensuring local execution aligns with Global Quality Standards while maintaining compliance with local regulatory requirements. This setup not only ensures strategic synergy across countries but also empowers our teams to excel in a dynamic, multicultural environment while maintaining a strong commitment to patients and excellence.

As part of the Iberia MCO, the position supports harmonization of processes, drives quality initiatives, and fosters collaboration and alignment across Portugal and Spain affiliates. The role also has close interaction to the Portugal leadership team, providing periodic strategic quality insights and support to achieve business objectives and projects. Additionally, it connects with Takeda’s Global Quality Organization to ensure consistent application of global systems and policies, promoting integration and operational excellence by means of working independently and committing to Takeda KPIs.

ROLE PURPOSE

• This role acts as an individual contributor in the Portuguese affiliate managing and execution of local GDP, R&D and QMS activities maintaining compliance both with local regulation and Takeda standards.
• This role is expected to have an active contribution in developing a strong QMS system, digital and efficiency oriented by means of strong digital capabilities.
• Support the achievement of business success with regards to GDP and quality related activities in the MCO. Responsible Person (RP) for Portugal LOC. Maintain the INFARMED (National Agency for medicines and Medical Devices) license of Takeda (Takeda Farmacêuticos Portugal LDA) for Wholesale Distribution of medicinal product and medical devices.
• Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging / analytical testing quality oversight, and in-country clinical and 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.
• Serves as the Quality point of contact in the Portugal LOC on quality matters and initiatives. Contribute to the achievement of business success.
• As Responsible Person (RP), decides independently from the management about the release, the block, or recall of batches. Take other QA relevant decisions independently, as needed.
• Supports a consistency and harmonized quality approach across the Portugal and Spain LOCs.
• Manage R&D QA system and execution of related activities

SKILLS AND QUALIFICATION

• Deep GDP and QMS knowledge
• Fulfillment of requirements to be a GDP responsible person in Portugal for Marketing Authorization Holders
• Pharmacy degree (fulfilling ORDEM DOS FARMACÊUTICOS Regulamento n.º 948/2024)
• Residence in Portugal
• High level of Portuguese
• High level of English
• Applies stong quality assurance principles and concepts in routine and urgent and demanding situations.
• Conducts audits, applying auditing principles in straightforward situations
• Identifies flaws and learns to apply corrective and preventive actions
• Applies investigation techniques, ensuring thorough examination and compliance
• Applies risk management techniques
• Follows established change control procedures , understanding their importance in quality management
• Fluent Quality Management Systems management, ensuring adherence to regulatory standards
• Focuses on details, identifying key elements in tasks to maintain high quality standards
• Strong interpersonal communication and negotiation skills to build long term relationships with Portuguese Leadership team at the LOC
• Strong digital dexterity
• In order to enable an efficient MCO setup, regular travelling is required across MCO.

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