WHAT YOU WILL DO
In this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Compliance Director 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 Japan.
The Quality Compliance Lead will manage end to end Quality Oversight for all local trials, and all associated suppliers/vendors operating within the country. 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 Clinical Research Quality Leadership Team, Global/Regional/Local study teams and all key stakeholders across Japan Development teams to ensure that all global and regional quality standards are maintained, and inspection ready.
This is a vital role who will develop a deep knowledge of the local market and Amgenâs clinical development strategy. This role also provides oversight and quality management of critical data and processes for local study teams, clinical trial sites, and all associated suppliers/vendors that operate within the country.
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 Risk Assessment Categorization Tool (RACT) 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 needs to be considered for clinical trials operating within Japan.
Provide oversight for the development and implementation of Quality Plans specifically suited within Japan. Â
Establish country level expertise to ensure quality and compliance to local regulations and international guidelines (e.g.: ICH GCP, WHO etc.)
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 Affiliate-specific Quality Assurance plans for application within the region, 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 local Clinical Trial and global/local cross-functional teams (e.g.: Clinical Operations, Project Management, Data Management, Statistics/Programmer, Pharmacovigilance, Regulatory Affairs, Medical Monitors etc.) for all quality management activities, including Issue Management (e.g., Deviations/CAPAs and Serious Breaches/ Privacy Issues), Risk Assessment, 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).
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:
Bachelorâs degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards Â
2 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 TrackWise. Â
Thorough understanding of Clinical R&D activities and Global/local Regulations
Good knowledge of Regulatory Submission and overall Inspection Management procedures expected by Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Experience in supporting regulatory inspections by overseas authorities (e.g. FDA, EMA), at Sponsor, CRO, or investigatorâsite level is preferred
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.
Business-level Proficiency in English and Japanese, both written and spoken, with the ability to communicate effectively in a global, crossâfunctional environment
International and Domestic Travel required (estimate 10%)
amgen