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Quality Management Systems Senior Specialist

1 week ago

Hong Kong, Central and Western District, Hong Kong SAR China Barrington James Full time
Quality Management Systems Senior Specialist

Are you an experienced and highly skilled pharmacist looking to take on a leadership role in shaping and maintaining quality management systems? Join a leading global pharmaceutical company with a rich history of innovation and a reputation for delivering high-quality medicines to markets worldwide. I am urgently hiring a Quality Management Systems Senior Specialist to ensure the highest standards of quality across our operations, products, and regulatory submissions, in Hong Kong.

About the Company

Our client is a global powerhouse, revolutionizing life science research and clinical diagnostics with cutting-edge products. Serving a diverse and dynamic clientele, from universities and research institutions to hospitals, biotechnology firms, and pharmaceutical companies, this company is making a real impact across multiple industries.

The Role

As the Senior Specialist, Quality Management Systems , you will be instrumental in the design, implementation, and continuous improvement of the Quality Management System (QMS) for our Hong Kong operations. You will ensure full compliance with global regulatory requirements and internal quality standards, supporting our mission to deliver innovative, high-quality products that drive progress in the life sciences and healthcare industries.

Key Responsibilities

  • Lead the setup and management of a comprehensive Quality Management System (QMS) aligned with regulatory requirements.
  • Serve as the registered pharmacist and license holder in Hong Kong, ensuring 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.

Must-Haves

  • 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.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Quality Assurance

Industries: Medical Equipment Manufacturing

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