QA Senior Manager_ Biopharma
On-siteTokyo, Tokyo, Japan
Job Summary
Manage day-to-day quality and compliance operations for Japan, ensuring GMP, GDP, and GQP requirements are met alongside local regulatory obligations. Lead the Quality Management System for the local subsidiary, oversee a team of quality professionals, and plan resource allocation for budget management. Handle change control, deviation management, complaint resolution, product recalls, and self-inspections while coordinating GMP inspection readiness for manufacturing sites. Maintain relationships with local health authorities, report quality performance indicators, and contribute to Quality Councils and Management Reviews. Act as Deputy of the Responsible Person of Quality (Hinseki). Requires 5+ years in pharmaceutical quality, fluency in English, and willingness to travel nationally and internationally.
Required Qualifications
- Degree in Pharmacy, Chemistry, Life Sciences, Pharmacology, Medicine, or a related scientific discipline, or equivalent professional experience in a pharmaceutical or healthcare quality environment
- At least 5 years of experience in the pharmaceutical or a related industry
- Solid background in quality assurance, GMP/GDP/GQP operations, or distribution and warehouse management
- Proven expertise in GDP and GQP specific to the Japanese market, including practical experience with the PMD Act and the Japan regulatory framework
- Experience leading and developing quality teams
- Ability to set clear objectives, support individual growth, and maintain a motivated and accountable team
- Effectiveness as a communicator and collaborator with internal stakeholders, external partners, and local health authorities, including in inspection and audit settings
- Solid analytical and problem-solving skills
- Ability to manage competing priorities and drive timely, well-documented resolution of quality issues
- Fluency in English (spoken and written)
- Willingness to travel nationally and internationally as required by the role
Desired Qualifications
- Proficiency in Japanese
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