Quality Lead​, Hong Kong​, CQ

Takeda · Hong Kong

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Job Description

About the role:

• As a core member of the China Commercial Quality team and the designated Responsible Person (RP) for GDP compliance i.e. Person in Charge (PIC) for Takeda Hong Kong Wholesale Dealer Licence (WDL) operations, provide quality oversight and regulatory accountability for the handling, storage, distribution, and supply of pharmaceutical products in compliance with applicable HK and Macau regulations and Takeda Quality Management System requirements
• Partnering closely with regional and global quality leaders, and cross functional stakeholders such as Commercial, Supply Chain, Regulatory Affairs, Pharmacovigilance and Medical. Serve as the quality point of contact with key Commercial Leaders & stakeholders in the market on quality matters and initiatives impacting the market.
• Support implementation of Commercial Quality programs, and continuous improvement initiatives while maintaining inspection readiness and an effective quality culture.
• Work independently under general direction, occasionally leading small project teams, and may represent the organization in project matters. You might also participate in training junior staff.

How you will contribute:

• Lead Hong Kong and Macau Commercial Quality activities in partnership with Regional CQ Leaders and serve as the strategic quality partner to Commercial, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Medical.
• Implement and maintain local Quality Management System (QMS) processes in compliance with applicable GDP requirements, local regulations, and Takeda standards; oversee distribution and storage controls, quality surveillance, product returns, batch disposition, deviations, CAPAs, and change management.
• Provide quality support and oversight for new product launch readiness and, where applicable, local contract manufacturing, packaging, analytical testing, GCP, GVP, medical device, Medical, PAP, and PSP activities.
• Take part in self-inspections, compliance monitoring, and quality risk management, and drive continuous improvement through process simplification, standardization, and digitalization.
• Maintain inspection readiness, host Health Authority inspections, manage regulatory communications for quality and compliance related matters, and lead the escalation and resolution of market-level product quality and compliance issues.
• Serve as the Hong Kong Person in Charge (PIC) for Wholesale Dealer Licence (WDL) activities, including:
  • Act as the designated Person in Charge (PIC) of poisons and/or pharmaceutical products for Takeda Hong Kong WDL activities and ensure compliance with the applicable regulatory requirements in HK.
  • Maintain oversight of all pharmaceutical product distribution activities, including receipt, storage, transportation, supply, returns, recalls, destruction and etc. of pharmaceutical products.
  • Approve and oversee the handling of returned pharmaceutical products, disposition decisions, and associated risk assessments.
  • Ensure appropriate controls are established and maintained for storage conditions, temperature monitoring, stock reconciliation, transportation, and distribution quality.
  • Review and approve WDL-related procedures, investigations, deviations, CAPAs, risk assessments, complaints, recalls, and quality system documentation.
  • Ensure all required records, supporting documentation, licences, batch records, and distribution records are complete, maintained, and readily available for HA inspections.
  • Lead regulatory inspections and licence maintenance activities related to the Hong Kong WDL and serve as the primary quality contact with the HK HA on wholesale dealer compliance matters.
  • Ensure product complaints, recalls, compliance and quality issues are appropriately investigated, documented, and reported to the HA when required.  
  • Identify, escalate, and drive remediation of quality, compliance, and business risks associated with licensed wholesale distribution activities.
  • Ensure GDP training completed and maintained through continuous professional development.

Minimum Requirements/Qualifications:

• Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Quality Management, or related discipline.
• Minimum 10 years of solid experience in pharmaceutical distribution, quality assurance, GDP/GMP compliance.
• Eligible for appointment as Person-in-Charge of Poisons and Pharmaceutical Products (PIC) under the HK Wholesale Dealer Licence framework.
• Strong knowledge of HK GDP requirements and relevant pharmaceutical legislation.
• Demonstrated competence in quality management systems, risk management, deviation/CAPA management, supplier qualification and product recalls.
• Experience in supporting regulatory inspections and interactions with Health Authorities
• Strong stakeholder management, communication, and influencing skills.
• Fluent in English, Mandarin and Cantonese.

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