The Development Quality Assurance Manager/Expert supports quality oversight for Novartis development activities in Japan. Responsibilities typically include reviewing clinical-development and GCP-related processes, assessing risks, managing deviations and CAPAs, supporting audits and inspections, and advising development teams on quality and compliance requirements. Candidates are expected to have experience in pharmaceutical quality assurance, clinical research, GxP, quality systems, audits, and relevant Japanese and international regulations. Strong communication, analytical, influencing, and project-management skills are important, along with the ability to work across global and local teams. Fluency in Japanese and business-level English may be required, and a degree in life sciences, pharmacy, medicine, or a related discipline is generally preferred.
Novartis is a global pharmaceutical company headquartered in Switzerland, focused on discovering and developing innovative medicines. Its major therapeutic areas include cardiovascular, renal and metabolic diseases, immunology, neuroscience, oncology, and hematology. The company operates across research, clinical development, manufacturing, regulatory affairs, and commercial functions, with employees working in many countries. Novartis emphasizes science-driven innovation, data, patient outcomes, ethical business practices, and collaboration across international teams. In Japan, it maintains a substantial presence supporting clinical development, regulatory activities, medical affairs, market access, and commercial operations. The company generally offers structured career development, international collaboration, and opportunities to contribute to medicines intended for significant unmet medical needs.
Japan offers strong opportunities in pharmaceuticals, healthcare, biotechnology, manufacturing, technology, finance, and engineering, particularly around Tokyo, Osaka, Yokohama, and Kobe. Workplace culture values punctuality, preparation, teamwork, respect for hierarchy, and careful attention to quality, although international companies often use more flexible practices. Lifestyle ranges from dense urban living to quieter regional communities, with excellent public transport, safety, healthcare, and convenience. Housing and commuting costs are highest in Tokyo. Foreign professionals normally need an appropriate work status, such as an Engineer/Specialist in Humanities/International Services visa or a Highly Skilled Professional visa; the employer commonly sponsors the application. Relocating employees should prepare academic and employment documents, secure housing, arrange health insurance and pension registration, and learn basic Japanese. Japanese language ability is valuable, especially in regulated and locally focused roles.
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