Quality Assurance Manager

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Job Description

Job Title: Quality Assurance Manager

Location: Seoul, Korea

About the role: 

 The role's purpose is to drive quality compliance to meet Health Authority and Takeda requirements are met, safeguarding PTRB (Patient, Trust, Reputation and Business) and aligning with the Local Operating Company (LOC) Korea business strategy.

The objectives include ensuring operational excellence in Quality Control lot release, maintaining an effective Quality Management System (QMS) through quality KPIs and a quality council, managing quality requirements for product launches, overseeing audits readiness for Health Authority inspections and leading Quality Control initiatives/projects including new/changed method transfers and analytical tests.

How you will contribute: 

• Managing quality operations for local Takeda product inventory in line with local GMP/GDP regulations and Takeda requirements, making timely decisions to maintain product quality and supply continuity.
• Managing the implementation and changes in quality requirements related to product launch and lifecycle management.
• Executing the quality governance activities in the LOC, including coordinating the Quality Councils, monitoring QA KPIs and maintaining the Quality Risk Register.
• Coordinating Health Authority inspection readiness and management activities.
• Leading annual quality projects related to local QC tests and testing service laboratories, including analytical method transfer and other changes.
• Managing issues during QP and local QC laboratory operations, ensuring timely coordination, effective investigation, and communication with stakeholders.
• Ensuring compliance with internal policies and external regulations, including Takeda Policies and Procedures and Health Authority Regulations in Korea.
• Executes quality improvement plans and supports Quality culture initiatives in the LOC.
• Providing subject matter expertise support for compliance and audit readiness of other Korea LOC GxP functions for internal and external audits

What you bring to Takeda: 

Essential (Mandatory):

• Bachelor's degree in Pharmacy and Registered Pharmacist.
• Minimum 8 years of Quality Assurance (QA) experience, including 5 years in analytical transfer project management, 5 years in local lot release, and 5 years in a multinational pharmaceutical company.
• Strong understanding of Pharmaceutical Quality Management Systems (QMS), cGMP, and quality management guidelines including QRM (e.g., PIC/s, ICH, local regulations).
• Solid understanding of Good Distribution Practice (GDP) and Marketing Authorization Holder (MAH) requirements.
• Pharma Quality Auditor experience, both external and internal, with skills in audit/inspection readiness and management.
• Ability to conduct effective quality investigations and technical problem-solving.
• Proficiency in recognizing and escalating potential reportable events.
• Effective interaction with Health Authorities/Competent Authorities.
• Quality management of third-party logistics and contract testing laboratories.
• Understanding of QA requirements and performance of GDP/GMP suppliers.
• Knowledge of Data Integrity as applicable to GxP-computerized systems in the LOC.
• Building a Quality Culture and Continuous Improvement mindset in the LOC and building partnership with other Quality functions.
• Effective stakeholder management skills

Desirable (Recommended):

• Total recommended career years: 13-20 years.
• Master's degree in analytical science or pharmaceutical science.

Leadership Behaviors:

• Think Strategically: Demonstrates strategic thinking to serve patients, build trust, reputation, and business.
• Inspire Others: Creates an inspiring environment to move the organization forward and Leads by example to demonstrates a positive attitude and cooperates as a team leader or member.
• Deliver Priorities: Focuses on key priorities and delivers superior results.
• Elevate Capabilities: Enhances the organization's capabilities for the present and future.

Critical Success Factors & Key Challenges:

• Ensuring all activities are compliant with internal policies and procedures and external codes and regulations
• Innovation in Simple process designs encapsulating a continuous improvement mindset
• Driving and building a Quality Culture in Commercial environment
• Building a risk-based approach to enable proactive and preventative issues management

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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