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Job Description

ACCOUNTABILITIES

Management of Quality System for Hong Kong and Macau:

• Own&Implement and maintain local quality system applying to GxP activities related to storage, distribution and commercialization of all products under development or marketed by Takeda or through partnership agreements, in compliance with Takeda Quality reference standards.
• Enhance quality culture & promote Quality mindset into the LOC level, working principles and ways of operating.
• Ensure appropriate communication of key messages pertaining to quality across the local organization, highlighting their possible business impact
• Lead and coordinate a network of professionals designated in HK involved in GxP and health-regulated activities and embark them to address all matters related to quality.
• Internal/External Quality Audits and GxP Regulatory Inspections
• Deviation and CAPA Management
• Own and Implement a process to manage deviations and CAPAs related to all GxP activities including those related to audits and inspection findings, across the country in a consistent manner, and train concerned affiliate associates accordingly
• Change Control Management
• Manage the changes that may impact GxP process or operations by leading multidisciplinary exchanges and actions plans when necessary
• Training
• Organize and manage information sharing, training sessions or programs related to processes owned by QA for concerned HK associates, according to Takeda standards and regulatory requirements
• Quality Management Review
• Conduct Quality council according to Global Takeda SOP
• Quality Agreement
• Ensure that valid and signed quality agreements (with the country as contract giver) are in place for all GxP activities under the responsibility of Quality within HK organization
• Product Release, Product Return, Product Recall and Redressing activities for all products to ensure the compliance of GMP, GDP standard, company’s requirements and relevant Hong Kong regulatory requirements
• Quality Oversight of locally managed GxP Suppliers

Quality of Products

• Product Complaints (PCs)
  • Manage product complaints received by the country according to Takeda processes, standards and appropriate tools in force, in connection with the concerned Global Quality function
• Product related Quality Events
  • Escalate quality events as necessary occurring at the local level according to defined processes and standards and manage subsequent quality alerts (as appropriate)
  • Provide support to the appropriate functions at local level and according to the defined responsibilities vis a vis regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)
• Other relevant Quality tasks, where applicable

Leadership

• An understanding of industry, scientific and regulatory trends and market conditions, to help deployment of QMS within Hongkong and Macau
• Effective communicator
• Ability to lead effectively through directing change as well as driving change by influence
• Ability to lead and engage in complex investigations and propose sound, scientific, and compliant resolutions
• Ability to coach and mentor colleague to support his development

Qualifications & Skills

Level of Education

• Bachelor degree or higher, with major in scientific, engineering, medical or equivalent discipline.

Working Experience in Relevant Field

• At least 5 years working experience in pharmaceutical industry
• Experience in interacting with health authorities, industry associations
• Experience in affiliate (commercial) quality management
• Fluent in Chinese and English speaking and writing

Professional Knowledge and Skills

• Digital and analytical skills
• Critical thinking and problem solving
• Strong communication skills in engaging local and global stakeholders (quality, manufacturing, supply chain, business, network)
• Strategic enterprise thinking with innovation mindset
• Leading and influencing in a matrix environment
• Fluent in Chinese and English, both written and spoken

Locations

Worker Type

Worker Sub-Type

Time Type