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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

Responsibilities:

• 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

Basic Qualifications

Master’s degree and 6 years of Quality or Operations experience

OR

Bachelor’s degree or and 8 years of Quality or Operations experience

Chinese Language fluency

English language fluency

Preferred Qualifications

• 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

Competencies:

• 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.