Job Description

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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 MCO. Responsible Person (RP) deputy for Spain LOC. Maintain the AEMPS (National Agency for medicines and Medical Devices) license of Takeda (Takeda Farmacéutica España S.A) 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, and internal standards and SOPs and continuous improvement.
• Key stakeholders support in the Iberia MCO 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.
• Support a harmonized quality approach across the Portugal and Spain LOCs
• Support R&D QMS maintenance
• Manage GxP regulated activities in Spain LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients promptly.
• 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 both for GDP and R&D activities. These include: change control, deviation, CAPA management, training, document management, complaint handling, vendor audits, internal audits & self-inspections and 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 our needs, 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 GDP implementation at Spain LOC including 3PL oversight.
• Ensure all relevant LOC colleagues performing GDPs related tasks are trained before performing activities and on a periodic basis.
• 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.
• Implement Supplier Quality Program at Spain LOC according to Takeda Global Quality requirements and regulatory expectations. Establish and maintain local GxP supplier quality agreement. Support new local GxP supplier/contractor audited and qualified before use. Support local Quality Council, monitor and report key performance indicators (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.
• Help prepare external quality agreement between business partners (distributors) and TPI-IB and/or Manufacturing release sites, as applicable.
• Support regulatory surveillance and intelligence in the Spanish 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.
• Ensure release to market activities in the Spain/Portugal LOCs are performed to enable continuous market supply.
• Support any GDP/GxP quality related activities across the Iberia MCO.
• Local GxP Training administrator for LOC Spain/Portugal
• Strengthen Quality Culture at LOC. Champion a culture of continuous improvement and implementation of best practices.
• Ensure that Quality Management System is implemented and maintained.
• Focus on the management of authorised activities and the accuracy and quality of records.
• Ensure that the products are released/stored/transported/distributed/destroyed on the Spanish 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 are implemented and maintained and GxP training at the LOC.
• Coordinating and promptly performing any recall operations for medicinal products.
• Resolve customer complaints and ensure suppliers and customers are approved and periodic license checked.
• Approve any subcontracted activities which may impact on GDP.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Keep appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled or falsified products.
• Approve any returns to saleable stock.
• Ensure additional requirements imposed on certain products by national law are followed.
• Report monthly to local Competent Authority the medical products distributed in the country.
• Ensure product defect reports and stock outs are adequately notified to AEMPS and recall execution in the territory
• Attend to management meeting for management review and risk assessment.
• Ensuring 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.
• Performing tasks to show that Takeda complies with GDP and public obligation are met.
• Ensure MAH responsibilities are fulfilled for the products where LOC is MAH
• Collaborate and partner well locally, within MCO Iberia Q-Team and cross-functionally with stakeholders.

What you bring to Takeda:

• Pharmacy master 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 working in a matrix management environment.
• Ability to lead by influence and conflict management.
• Fluent in written and spoken English.
• 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) deputy.
• Ability to drive change by influence.
• Understanding of industry, scientific and regulatory trends in the Geographic Scope, and its market conditions and requirements.
• Travel across LOC as needed, MCO and other EU countries (for training if needed)

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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