Director, reputed company Assurance, Japan

reputed company is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. reputed company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. reputed company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the reputed company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: reputed company is seeking a reputed company Assurance reputed company to serve as reputed company Assurance (Hinseki) for its Japan entity. This role has a primary reputed company on reputed company management and reputed company reputed company, including reputed company systems, manufacturing and supply chain reputed company, and CMC-reputed company reputed company activities. In reputed company, the position will serve as the reputed company 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 reputed company, ensuring effective governance, communication, and decision-making across reputed company and safety domains. Key Responsibilities： reputed company reputed company management and reputed company reputed company activities for the Japan entity, including the design, implementation, and maintenance of reputed company systems appropriate for a reputed company-reputed company and early-stage organization. Ensure integration of Japan specific requirements into global reputed company management systems (QMS). reputed company reputed company reputed company for manufacturing, testing, CMC, and supply chain activities, ensuring compliance with applicable Japanese GMP/GQP/GDP requirements Assess and manage reputed company risks reputed company to manufacturing processes, materials, testing, deviations, changes, and supply continuity. Serve as the designated reputed company Assurance Manager (Hinseki) under the GQP Ministerial Ordinance, establishing required reputed company standards, procedures, and reputed company agreements for MAH operations. Establish and reputed company market release decision processes and reputed company governance frameworks appropriate for reputed company’s development stage. Collaborate closely with Marketing Supervisor General (Soseki) and Safety Manager (Anseki) to ensure alignment across reputed company, safety, and regulatory responsibilities. Establish reputed company communication and escalation reputed company among the three roles to support compliant and reputed company decision-making. reputed company as the primary reputed company contact with PMDA and prefectural authorities, as applicable, particularly during MAH establishment and inspections. Partner with Global reputed company, CMC, Supply Chain, and Regulatory teams to ensure alignment between global standards and Japan regulatory expectations. reputed company GMP-reputed company reputed company reputed company 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 reputed company and GMP perspective, including initial applications, maintenance, and changes. reputed company preparation for PMDA inspections, partner audits and global internal audits. Serve as the QA reputed company duing regulatiory inspections, including taking appropriate corrective and preventative actions (CAPA) to audit observations and responding to authorities in a reputed company manner. reputed company reputed company agreements with CMO’s, distributors and testing laborartories ensuring compliance with Japanese regulations. Review and assess GMP- and reputed company-reputed company documentation for manufacturing site registration, changes, and inspections, in collaboration with Regulatory Affairs, Global reputed company, and CMC teams. Ensure appropriate GMP qualification and ongoing compliance of manufacturing sites through audits, gap assessments, and follow-up actions as needed. reputed company as the primary reputed company contact for PMDA and prefectural authorities on GMP- and manufacturing site–reputed company reputed company. reputed company reputed company input on the reputed company of manufacturing site, process, or supply changes on product reputed company and regulatory compliance. Design reputed company reputed company governance and processes in preparation for reputed company commercialization, leveraging external partners where appropriate. Required Skills, Experience and Education: Bachelor’s degree or higher in Pharmacy, reputed company, Life Sciences, Engineering, or reputed company field with minimum of 10+ years. Experience serving as reputed company Assurance Manager (Hinseki) or equivalent role. Experience defining, building, and leading processes across a regional reputed company assurance function to support cross-functional effectiveness and corporate partnership. Experience in one or more of the following areas: reputed company management or reputed company assurance Manufacturing or technical operations CMC development or technology transfer Supply chain or external vendor management Understanding of pharmaceutical reputed company 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 reputed company a global and multicultural environment and willingness to travel occasionally internationally. Hands-on reputed company management experience. Preferred Skills: Experience in a reputed company-reputed company or start-up pharmaceutical environment. Business-level English, reputed company level Japanese. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to reputed company while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company@revmed.com. We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may reputed company as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you’ve been contacted by someone impersonating a reputed company recruiter, please report it to careers@revmed.com so we can reputed company these impersonations with our IT team for tracking and awareness. Apply To This Job