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Qa Manager

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Amgen

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Location:
China , Shanghai

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The International & Distribution Quality (IDQ) team supports products to and in the market after our manufacturing sites have produced high-quality medicines for our patients. The China IDQ team is a commercial-facing group that has oversight over finished drug product distribution in China. This oversight includes business partners, Logistics service providers, distributors, wholesalers, contract packaging, import testing laboratories product complaints, and Affiliate QMS to ensure our products are safe and effective. The Manager Quality Assurance is responsible for leading and conducting the following Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities where required.

Job Responsibility:

  • Ensure quality oversight of product supply and commercial operations in China within the requirements of the Amgen QMS and the Chinese GSP /GMP regulatory requirements
  • Perform in-country disposition for imported products and status changes as required
  • Perform an assessment and/or approval of non-conformances/deviations and including temperature excursions
  • report to management on trends
  • Interface with partners and collaboration companies in China
  • Support of the region's programs and processes
  • Project lead or team member for China Quality Systems and may act as interface to quality/operations, customers, and other global project lead as required
  • Lead the development and strategy for the distribution quality oversight and requirements
  • Participate and provide quality support on the working teams for new product launches
  • Write/review/approve local and global documentation in accordance with relevant regulatory requirements and Amgen policy ensuring specifically that China GSP /GMP requirements are included
  • Represent China in Regional Management Review as SME
  • Write / Review supplier technical agreements or quality agreements which include Provide quality assessments for change control, risk management plans, transport lanes, temperature monitoring plans, periodic evaluations and management plans
  • Provide oversight of product complaints by ensuring all quality complaints are documented, evaluated, investigated within company policy and regulatory timeframe expectations
  • Generate product complaint monitoring reports and reports to management and commercial on trends
  • Provide quality guidance for commercial programs including patient support programs and Product Complaint training
  • Participate in regulatory inspection of Amgen manufacturing facilities as needed
  • Perform self-assessments of GMP/GSP processes
  • Perform Supplier Security Audit for Amgen internal customers
  • General project and system support for JAPAC IDQ

Requirements:

  • Master’s degree and 6 years of Pharmacy, medicine, biology, chemistry and other related majors and Quality or Operations experience OR Bachelor’s degree or and 8 years of Quality or Operations experience
  • Chinese Language fluency
  • English language fluency

Nice to have:

  • 8+ years of quality assurance or combination of quality manufacturing, and distribution experience in the biotechnology/pharmaceutical industry
  • Experience studying or working outside of China
  • Knowledge in manufacturing, investigations, CAPA, product release, validation and/or change control
  • Lead and practice in QMS establishment according to China GSP/GMP and related regulations, standards and guidelines that apply to biotech manufacturing
  • Ability to achieve established timelines and deliver results to meet or exceed department and company goals and objectives
  • Excellent communication skills both written and verbal
  • facilitate discussions and present to audiences at all levels of a site organization
  • Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing
  • Demonstrated ability to work as both a team player and independently

Additional Information:

Job Posted:
March 12, 2026

Work Type:
On-site work
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