Senior Quality Specialist Lisboa

Senior Quality Specialist
Lisboa
Lisboa, Lisboa, Portugal

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 with 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 working independently and committing to Takeda KPIs.

ROLE PURPOSE

• This role acts as an individual contributor in the Portuguese affiliate, managing and executing local GDP, R&D, and QMS activities, maintaining compliance with local regulations and Takeda standards.
• This role is expected to actively contribute to developing a strong QMS system that is digital and
  - oriented, leveraging digital capabilities.
• Support the achievement of business success regarding GDP and
  - related activities in the MCO. Responsible Person (RP) for Portugal LOC. Maintain the INFARMED (National Agency for Medicines and Medical Devices) license of Takeda for Wholesale Distribution of medicinal products and medical devices.
• Responsibilities include Gx
  P-regulated activities such as
  - country distribution quality, local Health Authority relationships, local quality surveillance, oversight of local contract manufacturing, packaging, analytical testing quality, and
  - country clinical and medical device activities.
• Collaborate with other Gx
  P and
  - Gx
  P functions focusing on patient needs, regulatory compliance, internal standards, SOPs, and continuous improvement.
• Serve as the Quality point of contact in the Portugal LOC on quality matters and initiatives, contributing to business success.
• As Responsible Person (RP), independently decide on batch release, blocking, or recall. Make other QA-related decisions as needed.
• Support a consistent and harmonized quality approach across Portugal and Spain LOCs.
• Manage R&D QA system and related activities.

SKILLS AND QUALIFICATIONS

• Deep knowledge of GDP and QMS
• Meet requirements to be a GDP Responsible Person in Portugal for Marketing Authorization Holders
• Residency in Portugal
• High proficiency in Portuguese and English
• Strong application of quality assurance principles in routine and demanding situations
• Experience conducting audits and applying auditing principles
• Ability to identify flaws and implement corrective and preventive actions
• Proficiency in investigation techniques ensuring thorough examination and compliance
• Application of risk management techniques
• Understanding of change control procedures and their importance in quality management
• Fluent in Quality Management Systems and regulatory standards adherence
• Attention to detail to maintain high quality standards
• Excellent interpersonal, communication, and negotiation skills to build
  - term relationships with the Portuguese Leadership team at the LOC
• Willingness to travel regularly across the MCO for operational efficiency.

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