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Job DescriptionAbout 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.
Responsibilities: Responsible Person (RP) deputy for Spain LOC.Maintain the AEMPS (National Agency for Medicines and Medical Devices) license of Takeda for Wholesale Distribution of medicinal products 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, and internal standards and SOPs and continuous improvement.Support key stakeholders in the Iberia MCO on quality matters and initiatives.Contribute to the achievement of business success.As Responsible Person (RP) deputy, decide independently from the management about the release, block, or recall of batches.Support a harmonized quality approach across the Portugal and Spain LOCs.Manage GxP regulated activities in Spain LOC to ensure compliance with 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 for both GDP and R&D activities.Develop and maintain GxP-related controlled documents in the LOC Quality Management System.Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions.Support GDP implementation at Spain LOC including 3PL oversight.Ensure all relevant LOC colleagues performing GDP-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.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.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.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 authorized 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 the release of all received products to distribution.Coordinate and promptly perform 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 and necessary corrective measures are put in place.Decide on the final disposition of returned, rejected, recalled, or falsified products.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.Collaborate and partner well locally, within MCO Iberia Q-Team and cross-functionally with stakeholders.What you bring to Takeda:Pharmacy master's degree.5 years on-the-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 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.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.
Takeda is proud of 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.
Locations: Madrid, Spain
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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