Head of Quality Assurance

The Company is seeking a Head of Quality Assurance to lead pharmaceutical quality assurance and build a globally aligned quality system. Responsibilities include maintaining and managing quality systems, overseeing product-related quality activities, and providing final approval for market release decisions, change management, and quality responses. The role also supports stable supply and regulatory compliance through collaboration with domestic and international teams, and involves responding to regulatory authorities on product quality matters. Candidates should have practical experience as a pharmaceutical Quality Assurance Manager or equivalent, including quality oversight at advanced pharmaceutical or manufacturing sites. Expertise in GQP, GMP, GCTP, and GDP is required, along with experience negotiating with regulatory authorities and responding to audits. A bachelor’s degree or higher in science or engineering is required, as are fluent Japanese and business-level English. Preferred qualifications include a medical license, global quality assurance management experience, and experience planning and executing quality strategies for new drug launches.