QA Senior Manager Biopharma

Job description

Your Role In this pivotal role, you will shape and oversee the local quality strategy for Japan, protecting patients and supporting reliable access to medicinal products. You will lead quality and compliance activities across good manufacturing practice, good distribution practice and good quality practice, translating global direction and the Pharmaceutical and Medical Device Act into practical standards and a robust quality management system. You will guide complex operational issues, including changes, deviations, complaints, recalls and corrective actions, while coordinating inspection readiness with manufacturing sites and health authorities. By advising local management, leading quality councils and management reviews, and connecting local, global and external stakeholders, you will strengthen performance, risk management and continuous improvement across the area. Who You Are Degree or equivalent background in pharmacy, chemistry, life sciences, pharmacology, medicine or a related field. At least 3 years of experience in the pharmaceutical or related industry, with exposure to quality assurance, manufacturing, distribution, warehouse operations or related activities. Practical experience with good manufacturing practice, good distribution practice and good quality practice in Japan, together with experience in quality assurance systems. Working knowledge of Japan’s regulatory framework, including the Pharmaceutical and Medical Device Act, and experience supporting health authority inspections. Experience managing quality processes such as change controls, deviations, technical complaints, product recalls or withdrawals, quality risk management and corrective and preventive actions. Ability to analyze complex operational issues, prioritize work and make sound decisions with substantial professional responsibility. Strong collaboration, negotiation and influencing skills to work effectively with local, global and external stakeholders. Willingness to travel nationally and internationally; basic project management experience and familiarity with standard office applications are beneficial.