Japan GxP Quality Assurance Lead

Revolution Medicines, Inc.; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Revolution Medicines is seeking an Associate Director, GxP Quality Assurance to lead the Japan Quality Assurance organization, developing systems, governance and regulatory readiness to support product launches and ongoing commercialization.

You will partner with the Head of Quality Assurance, oversee audits of CMOs, establish QTAs, ensure product release quality, and drive quality events, CAPAs, change controls and regulatory inspections across the Japan MAH framework.

Qualifications

• Bachelor’s degree or higher in a scientific field or related discipline.
• Minimum 5 years of Quality Assurance experience in pharma.
• Knowledge of GQP, GMP, GDP and applicable regulations.
• Experience supporting regulatory inspections and audits.
• Experience managing QA activities with GxP service providers (CMOs, logistics, warehouses, call centers).
• Experience in product release, Deviation, CAPA, Change Control, Quality Information and PQC management.
• Strong problem-solving and decision-making skills.
• Leadership in global, cross-functional settings.
• English (business) and Japanese language proficiency.

Responsibilities

• Establish and maintain the Quality Management System for the Japan MAH organization.
• Lead Quality Governance and strategic direction for Quality Systems and Compliance.
• Serve as Deputy of QAM and back-up for critical QA responsibilities.
• Drive continuous improvement of quality processes and compliance programs.
• Support product launch readiness and regulatory registrations in Japan.
• Audit external partners and manage QTAs with CMOs and providers.
• Oversee product release records, quality events, deviations, CAPAs and change controls.
• Coordinate regulatory inspection readiness and participate in inspections.

Skills

Leadership

Problem-solving

Global cross-functional

English proficiency

Japanese language

Education

Bachelor’s degree or higher in a scientific field (Pharmacy, Chemistry, Biology, Engineering, Biotechnology, Life Sciences)

5+ years Quality Assurance experience in pharma

Knowledge of GQP, GMP, GDP regulations

Experience with regulatory inspections & audits

Experience with CMOs, QTAs, quality events

Product release, Deviation, CAPA, Change Control, QI, PQ management

Leadership experience in global environments

Job description

Revolution Medicines is seeking an Associate Director, GxP Quality Assurance to lead the Japan Quality Assurance organization, developing systems, governance and regulatory readiness to support product launches and ongoing commercialization.

You will partner with the Head of Quality Assurance, oversee audits of CMOs, establish QTAs, ensure product release quality, and drive quality events, CAPAs, change controls and regulatory inspections across the Japan MAH framework.