Amgen Sr Qualıty Manager-China in Shanghai, China
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The International & Distribution Quality (IDQ) team supports product to and in the market after our manufacturing sites have produced the 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 LSP’s, distributors, wholesalers, contract packaging, import testing laboratories and product complaints to ensure our products are safe and effective.
The Senior Manager Quality Assurance is responsible for leading the following Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities where required.
To 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 programs and processes such as the China Taskforce and the following example
Project lead or team member for China Quality Systems and may act as interface to quality/operations, customers and other global project leads 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 program including patient support programs and Product Complaint training
Participate in regulatory inspection of Amgen manufacturing facilities
Perform self-assessments of GMP/GSP processes.
Perform Supplier Security Audit for Amgen internal customers
Incorporating Amgen policy requirements for vendor assurance
General project and system support for JAPAC IDQ
Lead projects that improve quality and gain efficiencies
Develop and monitor the budget for IDQ China
Master’s degree and 6 years of Quality or Operations experience
Bachelor’s degree or and 8 years of Quality or Operations experience
Chinese Language fluency
English language fluency
8+ years of quality assurance or combination of quality manufacturing ,distribution experience in the biotechnology/pharmaceutical industry
5+ years of management experience
Experience working outside of China
Knowledge in manufacturing, investigations, CAPA, product release, validation and/or change control
Practice in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment
Ability to develop meaningful team and staff goals, manage performance and mentor and develop staff
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
Decisive and independent risk-based decision-making ability where needed
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
Established Leadership capabilities
Passion for Operational Excellence
Communications skills, both oral and written, including executive presentation skills
Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
Ability to tactfully negotiate and positively influence peers and executive leadership
Analytical skills to identify potential improvement opportunities
Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
Strong collaborative working relationships with all stakeholders including local Commercial and local/global Operations stakeholders.
Continued product supply to patients through on time disposition and completion of quality activities relating to supply.
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.