Quality Assurance Manager

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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