Quality Systems Manager for Global Pharmaceutical Company

18 hours ago


Hong Kong, Central and Western District, Hong Kong SAR China Barrington James Full time
About the Role

As a Senior Specialist, Quality Management Systems, you will play a pivotal role in shaping and maintaining our Quality Management System (QMS) for our Hong Kong operations. Your primary responsibility will be to ensure full compliance with global regulatory requirements and internal quality standards.

Key Responsibilities:

  • Design, implement, and continuously improve our Quality Management System (QMS), ensuring it aligns with regulatory requirements.
  • Serve as the registered pharmacist and license holder in Hong Kong, guaranteeing adherence to local pharmaceutical regulations.
  • Develop, implement, and monitor standard operating procedures (SOPs), quality metrics, and continuous improvement initiatives.
  • Provide expert guidance on QMS matters and collaborate with cross-functional teams to drive quality enhancements.
  • Prepare for and support regulatory inspections, audits, and internal quality assessments.
  • Oversee the management of quality documentation and ensure timely reporting of quality-related matters to senior leadership.
  • Partner with global teams to ensure alignment of local processes with international standards and best practices.

Requirements:

  • Registered Pharmacist in Hong Kong with active licensure, as you will be the license holder for warehousing and import operations.
  • Extensive experience in setting up and managing Quality Management Systems (QMS) in the life science research and clinical diagnostic sectors.


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