💼 About This Role

You'll lead quality management and oversight for our Japan entity, ensuring compliance with Japanese GQP/GMP/GDP regulations. Your work will directly enable the launch of novel RAS-targeted cancer therapies and build scalable quality systems for future commercialization. You'll serve as the designated Hinseki under the GQP Ordinance, collaborating closely with Soseki and Anseki.

🎯 What You'll Do

• Lead quality management and oversight for Japan entity.
• Ensure integration of Japan-specific requirements into global QMS.
• Serve as designated QA Manager (Hinseki) under GQP Ordinance.
• Lead preparation for PMDA inspections and partner audits.

📋 Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 10+ years of quality assurance experience in pharmaceuticals.
• Experience serving as Quality Assurance Manager (Hinseki).
• Ability to communicate with Japanese health authorities in Japanese.

✨ Nice to Have

• Experience in pre-commercial or start-up pharmaceutical environment.
• Business-level English and native-level Japanese.

🎁 Benefits & Perks

• 🏖️ Flexible remote work
• 💊 Work on cutting-edge RAS-targeted therapies
• 🌍 Global and multicultural environment
• 🧳 Occasional international travel opportunities

📨 Hiring Process

Estimated timeline: 2-3 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min

🚩 Heads Up

• Role expects 10+ years experience, but company is pre-commercial/early-stage — potential mismatch between seniority and company maturity.
• Legal requirement to communicate with Japanese health authorities in Japanese (language barrier for non-native speakers).
• Combines QA, regulatory, manufacturing, and supply chain oversight — broad scope may lead to overload.