QA Senior Manager_ Biopharma

Senior Manager Quality Japan

Location: Tokyo

Your Role

Quality underpins every product that reaches a patient, and in this role, you will be the operational leader who ensures that standard is upheld across the Japanese market. As Senior Manager Quality Japan, you will manage the day-to-day quality and compliance operations for Japan, ensuring that GMP, GDP, and GQP requirements are consistently met in line with both local regulatory obligations and global quality frameworks.

Working within defined policies and in close collaboration with global quality functions, you will oversee the Quality Management System for the local subsidiary, lead a team of quality professionals, and take accountability for the performance and continuous improvement of all local quality activities. You will plan and allocate team resources, contribute to budget management, and ensure that each team member has the development support they need to perform at their best.

In this pivotal role, you will manage change control, deviation handling, complaint resolution, product recalls, and self-inspections, while coordinating GMP inspection readiness for manufacturing sites serving the Japan market. You will maintain productive relationships with local health authorities, report quality performance indicators to local management, and contribute to Quality Councils and Quality Management Reviews. Acting as Deputy of the Responsible Person of Quality (Hinseki) for the local legal entity, you will bring both technical depth and collaborative leadership to a role that sits at the heart of quality operations in Japan.

Who You Are

You hold a degree in Pharmacy, Chemistry, Life Sciences, Pharmacology, Medicine, or a related scientific discipline, or bring equivalent professional experience in a pharmaceutical or healthcare quality environment.

You have at least 5 years of experience in the pharmaceutical or a related industry, with a solid background in quality assurance, GMP/GDP/GQP operations, or distribution and warehouse management.

You bring proven expertise in GDP and GQP specific to the Japanese market, including practical experience with the PMD Act and the Japan regulatory framework.

You have experience leading and developing quality teams, with the ability to set clear objectives, support individual growth, and maintain a motivated and accountable team.

You are an effective communicator and collaborator, able to engage constructively with internal stakeholders, external partners, and local health authorities, including in inspection and audit settings.

You bring solid analytical and problem-solving skills, with the ability to manage competing priorities and drive timely, well-documented resolution of quality issues.

You are fluent in English (spoken and written); proficiency in Japanese is highly advantageous given the local regulatory and stakeholder environment.

Willingness to travel nationally and internationally as required by the role.