Merck Sharp & Dohme Corp is seeking an Associate Director of Supplier Quality Assurance in Tokyo, Japan, to ensure the quality and compliance of global API suppliers. The role requires extensive experience in GMP-regulated environments and leadership in quality assurance processes
Job Summary
This role serves as the primary Quality liaison for strategic API suppliers to ensure sustained compliance with global regulations and company standards.
The successful candidate will lead on-site and remote audits, drive effective corrective actions, and manage complex quality investigations including deviations and OOS events.
Candidates must possess strong bilingual communication skills in Japanese and English to effectively collaborate across global matrixed organizations and represent the company during regulatory interactions.
Matching Summary
Match Score: 85
Merck Sharp & Dohme Corp is seeking an Associate Director of Supplier Quality Assurance in Tokyo, Japan, to ensure the quality and compliance of global API suppliers. The role requires extensive experience in GMP-regulated environments and leadership in quality assurance processes.
Skills & Requirements
Must-have
8+ years GMP-regulated environment experience
Fluency in Japanese and English languages
Strong knowledge of EU FDA regulations
Experience with Annex 1 sterile manufacturing
Leading root cause analysis investigations
Managing supplier change controls
Nice-to-have
Formal auditor training or certification
Experience with electronic QMS systems
Background in biologics or vaccines
Direct regulatory inspection support experience
Proven ability to mentor teams
Key Requirements
Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, or Chemical Engineering
Minimum 8 years of experience in GMP-regulated environments
Willingness to travel approximately 25% domestically and internationally