Career Category

Job Description

Job Summary:

The Quality Director for Amgen China is a key member of Amgen International & Distribution Quality

JAPAC Team and leads all Quality activities related to the supply and distribution of

Amgen commercial products in China as well as management of the regional

Supply Security program and a team of Supply Security and Supplier Quality Management

personnel in China.

He or she is responsible for providing Quality oversight of Amgen GMP/GSP activities in China,

establishing and maintaining open and collaborative working relationships within China and

with global stakeholders.

Key Responsibilities:

• Develop and implement Quality strategy for Amgen in China and develop a strong collaborative

working relationship with local affiliate management and global functions as well as stakeholder

sites receiving supplies from China

• Lead and direct all aspects of the Quality function in China as required by Amgen Quality policies

and local regulations

• Lead and manage a program for the oversight and audit of Chinese suppliers to Amgen and its

subsidiary companies. These suppliers can include Active Pharmaceutical Ingredient (API)

and starting material manufacturers as well as raw materials, devices and finished products suppliers

• Provide Quality oversight of importers, distributors, logistics service providers (LSPs), and

suppliers, including selection and approval, due diligence assessment and (if needed) Person

in Plant placement

• Apply an advanced knowledge of Chinese and global market regulations to assess Supply Security

risks

• Maintain an active risk management program to appropriately deploy a team of auditors and Quality

Systems experts to the oversight of Amgen suppliers.

• As Quality leader for Amgen China, manage a team of diverse professionals in the development

of distribution channels, partnerships, and suppliers in China

• Implement, maintain and improve GMP/GSP Quality Management Systems (QMS) in accordance with

Chinese regulatory and Amgen standards

• Review and assess new and revised China regulations, standards and guidance related to

Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Chinese

Pharmacopoeia requirements; provide Amgen management and stakeholders with guidance and

interpretation on these standards and trends, as well as their implementation and enforcement

• Recruit, train, develop, motivate and retain staff Alert senior management of significant quality, compliance, supply and safety risks Actively engage in outside activities to enhance Amgen’s regulatory reputation in China and to foster relations with Chinese industry representative groups and regulatory agencies
• In partnership with the Regulatory organization, establish, maintain and improve an open and

collaborative working relationship with Chinese industry groups and where possible, the NMPA

and SIFDC/NIFDC

• Oversee and manage SIFDC/NIFDC import testing of commercial shipments

Basic Qualifications:

• Doctorate degree & 2 years of directly related experience OR

• Master’s degree & 6 years of directly related experience OR

• Bachelor’s degree & 8 years of directly related experience

• Fluent written and spoken Mandarin Chinese and English

Preferred Qualifications

• Doctorate +6 , Masters +10, Bachelors +12 years of directly related experience

• 5+ years managerial experience directly managing people including teams

•10 years Pharmaceutical/ healthcare experience, or biopharma preferred

• Pharmaceutical/biotech working experience outside of China.

• Extensive experience and/or education in Quality Management System, preferably with cold chain,

distribution and warehouse quality oversight

• Experience or broad understanding of Supplier Quality Management and the challenges of chemical

and material supply from China

• Excellent leadership and motivational skills, clear communication

• Cultural dexterity - experience working overseas for several years is highly beneficial

• Advanced knowledge of GxP regulations, compendia, guidance and industry practice as pertains

to the manufacture and testing of biological products

• Strong ability to manage timelines and deliverables, recognize issues and impacts, and take actions

rapidly and proactively

• Excellent verbal and written communication skills, including technical writing, in both English and Chinese

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.