Pharmaceutical Operations Director

We are conducting a confidential search for a Pharmaceutical Operations Director to lead manufacturing and supply operations for a pharmaceutical organisation based in Osaka, working on-site. Osaka is one of Japan's historic pharmaceutical manufacturing centres, and this is a director-level opportunity for an operations leader who can own PMDA inspection readiness and GMP compliance end-to-end.

In this role, you will own plant operations across formulation, packaging, and quality release, ensure inspection readiness and compliance under the PMDA regulatory regime and GMP requirements, and lead technology transfer of new products and dosage forms into the site. You will drive batch record review and deviation/CAPA management, and oversee validation lifecycle for equipment, processes, and cleaning across the facility.

You will build and lead a multi-shift operations organisation of managers, supervisors, and operators, partner with quality assurance, regulatory affairs, and supply chain on site capacity and inspection planning, and represent operations in PMDA inspections and corporate site reviews. You will also drive continuous improvement and digitalisation initiatives to lift right-first-time performance and inspection outcomes.

Nice to Have:

• Direct experience hosting PMDA inspections
• Background leading technology transfer into a Japanese GMP site
• Familiarity with Japanese pharmaceutical affairs law (Yakkiho)
• Six Sigma or Lean manufacturing certification
• Working proficiency in Japanese regulatory and quality documentation

Nice to have

• Direct experience hosting PMDA inspections
• Background leading technology transfer into a Japanese GMP site
• Familiarity with Japanese pharmaceutical affairs law (Yakkiho)
• Six Sigma or Lean manufacturing certification
• Working proficiency in Japanese regulatory and quality documentation