+ **WHAT YOU WILL DO** Let’s do this. Let’s change the world. In this vital role you will report to the China Quality Lead 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 the CRQ Leadership Team and all key stakeholders across China Development to ensure that all global and regional quality standards are maintained and aligned. 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. **RESPONSIBILITIES** + Review specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes. + Provide quality oversight and assess the Clinical Trial Risk Assessment Categorization Tool (CT-RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data/ processes and patient safety, welfare and rights. This also includes any country related risks that needs to be considered for clinical trials operating within China. + Collaborate on Therapeutic Area (TA) and Affiliate-specific Quality Assurance plans for application within China, so that they are fit for purpose, risk based and both efficient, and effective. This includes supplementing TA specific audit plans from China country perspective, and the execution of audits (investigator site audits, affiliate audits, and study level audits). Audit planning and support of audits by third parties will be required. + Support Clinical Trials operating within China and cross-functional teams for all quality management activities, including Issue Management (e.g., Deviations/CAPAs and Serious Breaches/ Privacy Issues), Audits and Inspection Management activities, including: + Conduct pre-inspection/mock inspection visits to sites. + Support China site inspections, including management of requests, and facilitation of interviews with regulators. + Coordinate audit and inspection responses and provide oversight for adequate root cause analysis and CAPAs. + Conduct new vendor qualifications/evaluations in a risk-based manner per global and local requirements. + Review local regulations and provide input to local and global SOPs. Help to interpret relevant regulations and guidelines and provide regulatory expertise for the China Development staff. Ensure Global SOPs are well understood, where applicable in China, leading and providing clarification on local implementation. + Prepare, analyze, and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key stakeholders. + Support the development and implementation of Quality Oversight Plans specifically suited within China. + Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice. + Liaise with the Clinical Quality Therapeutic Area Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods) + Liaise with Supplier Quality Leads and Precision Medicine Quality Leads to support Supplier/Vendor and In-Vitro Diagnostic compliance in China, aligning with global requirements. + Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods). + **WIN** **WHAT WE EXPECT OF YOU** 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: + Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.) + Minimum 7 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards + 3 years or more experience in **Quality Management** , **Quality Assurance** , or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. + Oversight and implementation of **Quality Management Systems** and experience managing quality in electronic QMS such as Veeva or Track wise. + Thorough understanding of **Clinical R&D activities and Global** **/** **China** **Regulations** + Knowledge of the **Regulatory Submission** and **Inspection Management** procedures in China **.** + **Quality Oversight of Clinical Trials** , including clinical trial protocol development, execution, and submissions. + Excellent verbal and written communication skills, including strong business writing abilities and active listening. + Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format. + Strong analytical, critical-thinking, and decision-making abilities. + Capability to understand and articulate technical concepts and literature in spoken and written **English/Mandarin** . + Travel required (estimate 20%)