Quality Assurance Manager

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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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

The capabilities required for this role are outlined below.

Essential (Mandatory)

• 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.

Critical Thinking and Leadership Behaviors

• Think Strategically: Demonstrates strategic thinking that supports patients, trust, reputation, and business outcomes.

• Inspire Others: Creates a motivating environment, leads by example, and works effectively as both a team leader and team member.

• Deliver Priorities: Focuses on key priorities and delivers strong results.

• Elevate Capabilities: Strengthens organizational capability for both current and future needs.