Senior Manager, Clinical Quality Assurance, Japan
The Opportunity:
The Sr Manager, Clinical QA serves as the Revolution Medicines Japan quality lead for GCP, GVP and GPSP quality oversight, quality systems management, vendor oversight, regulatory inspection support and inspection readiness activities.
This role partners closely with Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Global Quality, CROs and external vendors to ensure compliance with applicable GCP, GVP, GPSP, and related regulatory requirements in Japan, while driving risk-based quality management and continuous improvement initiatives.
GCP Quality Assurance
Lead and support regulatory inspections and inspection readiness activities.
Provide risk-based quality oversight of CROs, laboratories, eTMF providers, and other clinical vendors.
Partner with Clinical Development to promote GCP compliance.
Perform quality reviews of key documents, records, and operational processes.
Plan, conduct, and follow up on audits, inspections, and vendor audits.
Support investigations, deviation management, CAPA activities, and root cause analyses.
Provide quality guidance and support to clinical study teams
GVP Quality Assurance
Provide quality oversight of post-marketing surveillance activities conducted in accordance with GPSP requirements.
Establish, maintain, and continuously improve GPSP-related SOPs and quality systems.
Perform quality reviews of processes, records, and deliverables associated with post-marketing surveillance activities.
Assess and manage GPSP-related deviations, CAPAs, quality events, and quality risks.
Support GPSP-related audits and regulatory inspections.
Oversee vendors supporting post-marketing surveillance activities and monitor performance.
Collaborate with Pharmacovigilance, Medical Affairs, and Regulatory Affairs to ensure compliance with applicable requirements.
Quality Systems & Inspection Readiness
Support the development, maintenance, and continuous improvement of the Japan Quality Management System (QMS).
Develop, maintain, and manage SOPs and related quality documents.
Monitor regulatory developments and incorporate applicable requirements into quality systems.
Escalate significant quality risks and issues that may impact patient safety.
Establish and maintain inspection readiness programs and inspection management processes.
Promote a culture of quality and continuous improvement across the organization.
Required Skills, Experience and Education:
Bachelor's degree or higher in Pharmacy, Life Sciences, Biology, Chemistry, Engineering, Biotechnology, or a related scientific discipline.
Minimum 3 years of quality assurance experience related to GCP, GVP and/or GPSP within the pharmaceutical industry.
Knowledge of GCP, GVP, GPSP, applicable regulations and industry best practices.
Experience supporting regulatory inspections and inspection readiness activities.
Experience overseeing CROs, PV vendors, post-marketing surveillance vendors, and other GxP service providers.
Experience with audits, investigations, deviation management, CAPA management, and quality risk management.
Problem-solving, communication, and stakeholder management skills.
Ability to manage multiple priorities in a global, cross-functional environment.
Business-level English proficiency and native-level Japanese proficiency.
Preferred Skills:
Experience supporting product launch readiness and post-marketing quality activities within an MAH organization.
Experience establishing, maintaining, or improving Quality Management Systems (QMS).
Experience working within outsourced or virtual development models.
Experience implementing Risk-Based Quality Management (RBQM) programs.
Experience supporting oncology clinical development programs.
Experience using electronic Trial Master File (eTMF) systems and supporting TMF inspection readiness activities.
Experience as a GxP auditor, including internal, vendor, and supplier audits.
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