Senior Product Quality Lead – Japan Launch Readiness

Revolution Medicines, Inc.; United States; Presencial; USD 76 000 - 114 000; Tempo integral

Resumo da oferta

Revolution Medicines seeks a Senior Manager, Product Quality Assurance to serve as a Product Quality Representative within the Japan Quality Assurance organization. This role drives QA activities across the product lifecycle and leads product quality tasks including release support, information management, complaints, recalls, and regulatory inspection readiness.

The position collaborates with internal and external stakeholders to promote quality processes, investigations, risk assessments, and

Qualificações

• Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Engineering, Science, Biotechnology, or related field.
• Minimum 3 years QA experience in pharmaceutical industry.
• Knowledge of GQP, GMP, GDP and applicable pharmaceutical regulations.
• Experience supporting regulatory inspections and audits.
• Experience with GxP service providers (CMOs, logistics, warehouses, call centers).
• Experience with product release, deviation management, CAPA, change control and product quality complaints.

Responsabilidades

• Drive QA processes within areas of responsibility and maintain cross-training.
• Lead QA activities supporting product launch readiness in Japan.
• Manage quality audits of external partners and QTAs with CMOs and providers.
• Review quality records and support release decisions.
• Lead Deviations, CAPAs, Change Controls and Quality Information management.
• Collect data for APRs and Management Reviews; drive quality improvements.
• Support regulatory inspections and audits; maintain inspection readiness.

Conhecimentos

Quality Assurance experience

GxP knowledge

GMP/GDP knowledge

Regulatory inspections experience

Experience with CMOs and QTAs

CAPA / Deviation / Change Control

Cross-functional collaboration

English & Japanese language skills

Formação académica

Bachelor's degree or higher in Pharmacy or related science

Descrição da oferta de emprego

Revolution Medicines seeks a Senior Manager, Product Quality Assurance to serve as a Product Quality Representative within the Japan Quality Assurance organization. This role drives QA activities across the product lifecycle and leads product quality tasks including release support, information management, complaints, recalls, and regulatory inspection readiness.

The position collaborates with internal and external stakeholders to promote quality processes, investigations, risk assessments, and