Quality Assurance Manager

Description

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.

Qualifications

Highest qualification: University

• Bachelor’s degree in Pharmacy and registration as a licensed pharmacist.
• At least 10 years of Quality Assurance experience, including analytical method transfer project management.

Core Competencies and Skills:

• Strong knowledge of Pharmaceutical Quality Management Systems (QMS), cGMP, and quality risk management guidelines, including PIC/S, ICH, and local regulations.
• Solid understanding of Good Distribution Practice (GDP) and Marketing Authorization Holder (MAH) requirements.
• Audit experience in pharmaceutical quality, including both internal and external audits, inspection readiness, and audit management.
• Ability to conduct effective investigations and solve technical quality issues.
• Ability to identify and escalate potentially reportable quality events.
• Experience working with Health Authorities and other competent authorities.
• Experience managing quality oversight of third-party logistics providers and contract testing laboratories.
• Understanding of QA requirements for GDP and GMP suppliers.
• Knowledge of data integrity requirements for GxP computerized systems in the LOC.
• Ability to build a strong quality culture and continuous improvement mindset, while partnering effectively with other quality functions.
• Strong stakeholder management skills.