Quality Compliance Lead, Sr Manager

Let’s do this. Let’s change the world. In this vital role you will report to the China Quality Compliance, Associate Director, JAPAC Quality within Clinical & Research Quality (CRQ). The Quality Compliance Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development programs within China.  

The Quality Compliance Lead will manage end to end Quality Oversight for assigned clinical trials, associated local procedures, and suppliers/vendors operating within China. The Quality Compliance Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).  In addition, the Quality Compliance Lead will form a partnership with various R&D Quality Teams, cross-functional team members, Global/Regional/Local Leaderships and all key stakeholders across China Development to ensure that all quality standards are maintained.

This is a vital role who will develop a deep knowledge of the China market and Amgen’s clinical development strategy. This role also provides oversight and quality management of critical data and processes for regional/local study teams, clinical trial sites, and all associated suppliers/vendors that operate within the region.

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We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications: