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