What you’ll do
In this role, key responsibilities will include:
• As member of the China & Global QARA Leadership teams you will be Partnering internally and globally with external stakeholders, managing world-class the Quality Assurance program for China to enhance growth.
• Managing global GXP Quality Assurance processes, implementing QA initiatives/audit programs, including IT QA projects and continuous improvement.
• Managing quality system which provides guidance, tracking, and metrics of compliance.
• Managing the QARA team supporting China, aligning with Global members as required
o Overseeing QA RA processes such as CAPA, Case management… process to ensure timely implementation, and escalation, where necessary.
o Overseeing your team in conducting audits of company systems, CRAs, sites, external vendors and GMP audits as needed and ensures appropriate follow-up.
o Developing and leading audit /inspection readiness activities to ensure staff members are prepared for participation in regulatory inspections and audits. Assisting in facilitating client audits and regulatory inspections.
o Securing & maintaining all Regulatory requirements for our products and services in China
• Leading investigations (in collaboration with Global teams) and being a point-of-contact for customers during customer cases and field actions.
• Accountable for setting & monitoring Quality KPI's including, reporting on performance/ trend insights within business review and collaborating with QA associates and Cytiva leaders within the sites.


Who you are
• Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to Chinese and international standards.
• Strong leadership skills, ability to develop the Team and Influence senior leadership on QARA strategic direction
• Strategic growth enabler for the future of China segment
• Heavy ability to partner and drive change

其他信息

行业要求：全部行业