Quality Compliance Lead, Sr Manager

Amgen · Shanghai

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Job Description

• WHAT YOU WILL DO

  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.

  RESPONSIBILITIES

• Review specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes.
• Provide quality oversight and perform risk assessment for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights. This also includes any country-related risks that are to be considered for clinical trials operating within the country.  
• Responsible for the development and implementation of Quality Plans specifically suited within the region.
• Establish country level expertise to ensure quality and compliance to local regulations
• Liaise with the Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Collaborate on TA and local specific Quality Assurance plans for application, so that they are fit for purpose, risk based and efficient.  This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits).
• Support China Clinical Trial and cross-functional teams for all quality management activities, including Issue Management (e.g., Deviations/CAPAs and Serious Breaches/ Privacy Issues), Inspection Readiness activities, Audits and Inspection Management activities.
• Prepare, analyze and communicate compliance metrics/trends on a periodic basis to key stakeholders, senior leaderships and provide recommendations
• 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).
• 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.

• 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  
• 4 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 / Regional / China Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures. 
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• People leadership and managerial/mentoring expertise.
• 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.
• Local Travel required (estimate of 20%), overseas travel may also apply depending on business needs

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