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Job Description

About the Role:

As the Senior Quality Specialist, you will support the achievement of business success with regards to GDP and quality related activities in the MOC (Multi-Country Organization). Responsible Person (RP) for Portugal LOC (Local Operating Company). 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.

How you will contribute:

• 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.
• Contribute to R&D system maintenance.
• Manage GxP regulated activities in Portugal LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.
• Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.
• Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC. These include but are not limited to change control, deviation, CAPA management, training, document management, complaint handling, 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.
• Support effective GDP implementation at Portugal LOC including 3PL oversight.
• Ensure all relevant LOC colleagues performing -related tasks are appropriately trained prior to performing activities.
• Implement Supplier Quality Program at Portugal LOC according to Takeda Global Quality requirements and regulatory expectations. Establish and maintain local GxP supplier quality agreement. Ensure new local GxP supplier/contractor audited and qualified before use.
• Support local Quality Council on a regular basis, monitor and report key performance indica-tors (KPIs) according to Takeda Global Quality requirements.
• Perform self-assessments to monitor compliance with applicable procedures and requirements.
• Manage inspections/audits and ensure LOC audit/inspection readiness.
• Lead or support local Health Authority communication on product quality issues.
• Maintain oversight of contracts and quality agreements on LOC level.
• Support the preparation of external quality agreement between business partners (distributors) and TPI-IB and/or Manufacturing release sites, as applicable.
• Support regulatory surveillance & intelligence in the Portuguese LOC for new or emerging regulations.
• Ensure there is quality oversight of local GVP/Devices/Medical related activities, such as for local studies (e.g., Investigator Initiated Trials (IITs), Collaborative studies, Interventional studies (NI), Non-Interventional Studies (NIS) & activities impacting the PV system, e.g. PV, Regulatory Affairs activities.
• Local GxP Training administrator for LOC Spain/Portugal.
• Manage submissions of MIF/OCABR for plasma products in LOC Spain/Portugal.
• Manage submissions of import/export permits for controlled substances in LOC Spain/Portugal.
• Ensure release to market activities in the Spain/Portugal LOCs are timely performed to enable continuous market supply.
• Support any GDP/GxP activities across the Iberia MCO as required, depending on business needs.
• Strengthen Quality Culture at LOC. Champion a culture of continuous improvement and implementation of best practices.

Responsible Person accountabilities

• Ensure that Quality Management System is implemented and maintained.
• Focus on the management of authorised activities and the accuracy and quality of records.
• Ensuring that the products are released/stored/transported/distributed/destroyed on the Portuguese market adequately.
• Ensure effective 3PL oversight.
• Ensure and supervise a process for release of all received products to the distribution.
• Ensure that initial and continuous GDP training to key personnel is implemented and maintained and GxP training at the LOC.
• Coordinating and promptly performing any recall operations for medicinal products.
• Ensure that relevant customer complaints are dealt with effectively.
• Ensure that suppliers and customers are approved and periodic license check.
• Approve any subcontracted activities which may impact on GDP.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Keep appropriate records of any delegated duties.
• Decide on the final disposition of returned, rejected, recalled or falsified products.
• Approve any returns to saleable stock.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Report monthly to local Competent Authority the medical products distributed in the country.
• Ensure product defect reports and stock outs are adequately notified to INFARMED.
• Ensure effective recall execution in the territory.
• Attend to management meeting for management review and risk assessment.
• Ensure GDP audits are performed according to internal planning.
• Ensure that non-conform products are decommissioned and destroyed.
• Notify MAH and Competent Authority in case of non-conform products, recall, potential falsified products according to legislation.
• Perform duties to show that Takeda complies with GDP and public obligation are met.

What you bring to Takeda:

• Portuguese pharmacy degree.
• 5 years on job experience in a 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.
• Critical Thinking. Investigation and problem solving and Ability to manage complexity & balance priorities.
• Good communication and stakeholder management skills.
• Risk identification, evaluation, and management.
• Continuous improvement.
• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.
• Travel across LOC as needed, MCO and other EU countries (for training if needed)

Technical/Functional (Line) Expertise

• Strong knowledge of the regulations in the Geographic Scope and EU.
• Deep understanding of LOC/Commercial Quality requirements, including in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints), and contract manufacturing quality oversight.
• Meet other Legal local requirements for being Responsible Person (RP)

Leadership

• Ability to collaborate and partner well locally, within MCO Iberia Q-Team & cross-functionally with stakeholders.
• Ability to drive change by influence.
• Strategic enterprise thinking, finding innovative ways to serve patients, build reputation and trust.
• Delegate for Commercial Quality Iberia MCO Quality Head.

Decision-making and Autonomy

• Responsible to anticipate potential problems and risks related to quality system / regulatory expectations and implement solutions.
• Responsible for timely execution of market actions and Health Authority communications in the region once the decision had been aligned.

Interaction

• Key interactions with LOCs and MCO Iberia QA colleagues to improve performance & maintain compliance.
• Key interactions with LOC leaders/GMs and other key stakeholder groups including Regulatory Affairs to stay abreast with business and LOC strategy and respond promptly to evolving business needs.

Innovation

• Understanding of industry, scientific and regulatory trends in the Geographic Scope, and its market conditions and requirements.

Complexity

• Multiple countries, regulatory frameworks, clinical study and medical device requirements, and a wide diversity of products.

More about us:

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