Job Information
Amgen QA Sr Mgr in Shanghai, China
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.