Director, Quality Assurance, Japan

The Opportunity:

Revolution Medicines is seeking a Quality Assurance professional to serve as Quality Assurance  (Hinseki) for its Japan entity.

This role has a primary focus on quality management and quality oversight, including quality systems, manufacturing and supply chain quality, and CMC-related quality activities. In addition, the position will serve as the Quality Assurance  (Hinseki) as defined under the Japanese GQP Ordinance, supporting the establishment and maintenance of the Japan Marketing Authorization Holder (MAH).

The position also works closely with Marketing Supervisor General (Soseki) and Safety Manager (Anseki) as part of the legally required three-role framework, ensuring effective governance, communication, and decision-making across quality and safety domains.

Key Responsibilities：

• Lead quality management and quality oversight activities for the Japan entity, including the design, implementation, and maintenance of quality systems appropriate for a pre-commercial and early-stage organization.

• Ensure integration of Japan specific requirements into global quality management systems (QMS).

• Provide quality oversight for manufacturing, testing, CMC, and supply chain activities, ensuring compliance with applicable Japanese GMP/GQP/GDP requirements

• Assess and manage quality risks related to manufacturing processes, materials, testing, deviations, changes, and supply continuity.

• Serve as the designated Quality Assurance Manager (Hinseki) under the GQP Ministerial Ordinance, establishing required quality standards, procedures, and quality agreements for MAH operations.

• Establish and oversee market release decision processes and quality governance frameworks appropriate for the company’s development stage.

• Collaborate closely with Marketing Supervisor General (Soseki) and Safety Manager (Anseki) to ensure alignment across quality, safety, and regulatory responsibilities.

• Establish clear communication and escalation pathways among the three roles to support compliant and timely decision-making.

• Act as the primary quality contact with PMDA and prefectural authorities, as applicable, particularly during MAH establishment and inspections.

• Partner with Global Quality, CMC, Supply Chain, and Regulatory teams to ensure alignment between global standards and Japan regulatory expectations.

• Lead GMP-related quality oversight for both domestic and foreign manufacturing sites supplying products for the Japan MAH.

• Support registration, accreditation, and ongoing compliance of domestic and foreign manufacturing sites from a quality and GMP perspective, including initial applications, maintenance, and changes.

• Lead preparation for PMDA inspections, partner audits and global internal audits.

• Serve as the QA lead duing regulatiory inspections, including taking appropriate corrective and preventative actions (CAPA) to audit observations and responding to authorities in a timely manner.

• Oversee quality agreements with CMO’s, distributors and testing laborartories ensuring compliance with Japanese regulations.

• Review and assess GMP- and quality-related documentation for manufacturing site registration, changes, and inspections, in collaboration with Regulatory Affairs, Global Quality, and CMC teams.

• Ensure appropriate GMP qualification and ongoing compliance of manufacturing sites through audits, gap assessments, and follow-up actions as needed.

• Act as the primary quality contact for PMDA and prefectural authorities on GMP- and manufacturing site–related matters.

• Provide quality input on the impact of manufacturing site, process, or supply changes on product quality and regulatory compliance.

• Design scalable quality governance and processes in preparation for future commercialization, leveraging external partners where appropriate.

Required Skills, Experience and Education:

• Bachelor’s degree or higher in Pharmacy, Chemistry, Life Sciences, Engineering, or related field with minimum of 10+ years.

• Experience serving as Quality Assurance Manager (Hinseki) or equivalent role.

• Experience defining, building, and leading processes across a regional quality assurance function to support cross-functional effectiveness and corporate partnership.

• Experience in one or more of the following areas:

  • Quality management or quality assurance

  • Manufacturing or technical operations

  • CMC development or technology transfer

  • Supply chain or external vendor management

• Understanding of pharmaceutical quality regulations (GQP/GMP/GDP).

• Ability to communicate with Japanese health authorities in Japanese.

• Strong strategic thinking, analytical, and problem-solving skills with good communication, presentation, and interpersonal skills.

• Experience within a global and multicultural environment and willingness to travel occasionally internationally.

• Hands-on quality management experience.

Preferred Skills:

• Experience in a pre-commercial or start-up pharmaceutical environment.

• Business-level English, Native level Japanese.

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