Amgen Australia Pty Ltd is seeking a Quality Manager for its China operations to oversee compliance with GSP/GMP regulatory requirements and ensure the quality of drug distribution. The role involves leading quality assurance activities, collaborating with partners, and supporting new product launches in a dynamic and compliance-driven environment
Job Summary
The China IDQ team is a commercial-facing group that has oversight over finished drug product distribution in China, ensuring products are safe and effective.
The Manager Quality Assurance is responsible for leading and conducting Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities.
Responsibilities include ensuring quality oversight of product supply, performing in-country disposition, assessing non-conformances, and leading the development of distribution quality strategies.
Matching Summary
Match Score: 85
Amgen Australia Pty Ltd is seeking a Quality Manager for its China operations to oversee compliance with GSP/GMP regulatory requirements and ensure the quality of drug distribution. The role involves leading quality assurance activities, collaborating with partners, and supporting new product launches in a dynamic and compliance-driven environment.
Skills & Requirements
Must-have
Product distribution oversight in China
GSP/GMP regulatory requirements
Quality management system
Supplier technical agreements
Product complaint oversight
Regulatory inspection participation
Nice-to-have
Leadership capabilities
Passion for operational excellence
Strong collaborative partnerships
Analytical skills for improvement
Knowledge of industry trends
Key Requirements
Master’s degree and 6 years of relevant experience OR Bachelor’s degree and 8 years of experience
Chinese Language fluency
English language fluency
8+ years of quality assurance experience in biotech/pharma