Quality Assurance Manager

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s [Privacy Notice](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/).  I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** ------------------- **_ACCOUNTABILITIES_** Key responsibilities for this role are grouped below for clarity. **1\. Quality Leadership and Compliance** * Serve as the licensed pharmacist support and back-up for the Takeda Korea Quality Head, ensuring compliance with Takeda policies, local health authority requirements, and importation and distribution regulations in Korea. * Maintain required licenses, permits, and product or package registrations, and ensure related compliance workflows are completed on time. **2\. Product Quality Operations** * Manage day-to-day Product Quality operations, including product release, SAP disposition, returns, rejected or damaged goods, temperature excursions, transport or distribution deviations, and complaint handling. * Oversee routine quality activities supporting commercial supply, including release readiness, Plasma Master File management, recyclable bottle product management, and distribution controls. * Ensure timely completion of the local Annual Product Quality Review. **3\. Distribution** **partner** **and** **Supplier** **Oversight** * Provide QA oversight of distributor partners and suppliers and subcontracted activities, including audits, quality technical agreements (QTAs), partner qualification, product launches, and critical change controls that may affect GDP compliance. * Support shipment documentation and cross-functional communication related to customs clearance, import permits, and supply chain coordination. **4\. Governance, Inspection Readiness, and Improvement** * Coordinate LOC quality governance activities, including Quality Councils, QA KPIs, and maintenance of the Quality Risk Register. * Quality expert for MFDS or other HA inspection and communication and support internal and external audit preparation across Korea LOC GxP functions. * Lead self-inspections performed at defined intervals following a annual schedule. * Manage quality requirements for product launches, lifecycle changes, and continuous improvement initiatives that strengthen the local quality culture. **5\. QC and Laboratory Support** * Lead annual quality projects related to local QC testing and contract laboratories, including method transfer, testing changes, issue resolution, and stakeholder communication. * Manage testing fees, equipment procurement, and the purchase of reference standards and reagents required for product testing. **Locations** ------------- Seoul, Korea **Worker Type** --------------- Employee **Worker Sub-Type** ------------------- Regular **Time Type** ------------- Full time