Korea, Quality Head

PURPOSE OF JOB/POSITION

The Associate Director Commercial Quality is responsible for ensuring the quality of processes and product outputs. This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and local regulatory requirements in Korea. By maintaining high-quality standards, this role supports Takeda's mission to bring better health to people and a brighter future to the world.

ACCOUNTABILITIES

• • Ensure excellence and integrity in quality operations, process and systems, adhering to GxP regulations (including but not limited to GMP, GDP, GLP), as well as Takeda requirements, while maintaining audit readiness and compliance with internal and external regulations.
  • Develop and manage local Quality systems to secure necessary Pharmaceutical Licenses and Permits for importing and distributing Takeda products in Korea.
  • Implement Corrective and Preventive Action strategies, conduct audits, and manage investigations independently in routine and moderately complex situations.
  • Oversee local in-country testing processes, including method validation and analytical method transfer, outsourced to Analytical Contract Laboratories.
  • Coordinate LOC Quality goals and foster learning to enhance team capabilities, while driving leadership development to retain resources essential for compliance and operations.
  • Manage and oversee supplier relationships, including 3PL, contract laboratories, and other GxP vendors, to ensure quality and efficiency in operations, aligning with compliance requirements and business objectives.
  • Manage OPEX and CAPEX budgets for LOC Quality, ensuring efficient allocation of resources to support the Quality team’s objectives.
  • Enhance Quality collaboration for LOC Korea, supporting existing business and new product launches, acting as a key Quality interface with local suppliers, customers, and stakeholders to ensure timely delivery of compliant products.
  • Manage relationships with local GDP/GMP authorities and host or support inspections to ensure compliance and audit readiness.
  • Drive continuous improvement initiatives and execute quality improvement plans to enhance the Quality culture within the LOC, focusing on Quality KPIs and Risks.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential (Mandatory)

Core Competencies / Skills

Critical Thinking

• • Bachelor's degree in Pharmacy and Registered Pharmacist
  • Minimum of 10years experience in Quality Assurance, with a proven track record in implementing and maintaining QA processes to ensure compliance with industry standards and regulatory requirements and including 5 years of people manager experience
  • Proficiency in Good Laboratory Practices, including a strong understanding of Quality Control testing, method validation, and method transfer principles.
  • 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) / Good Manufacturing Practice (GMP) and Marketing Authorization Holder (MAH) requirements and other GxP standards as relevant.
  • Proficiency in English, both written and verbal, to effectively communicate and collaborate within a global team environment.
  • 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.
  • Investigation and problem solving
  • Strong communication and stakeholder management skills
  • Agility and ability to manage complexity & balance priorities.
  • Risk identification, evaluation, and management.