Play a pivotal role in ensuring the integrity and safety of our products through strategic oversight of global API suppliers
Job Summary
Play a pivotal role in ensuring the integrity and safety of our products through strategic oversight of global API suppliers.
Serve as the primary Quality liaison for strategic API suppliers, ensuring sustained compliance with GMP, company standards, global regulations, and the company Quality Manual.
Lead investigations into deviations, OOS/OOT, microbiological excursions, stability issues, and complaints, ensuring robust root-cause analysis, remediation, and required regulatory reporting.
Matching Summary
Play a pivotal role in ensuring the integrity and safety of our products through strategic oversight of global API suppliers.
Skills & Requirements
Must-have
Supplier Quality Assurance
GMP compliance
global regulations
Quality Agreements
risk-based tools
CAPA verification
Nice-to-have
strong quality culture
global, virtual, matrixed environment
cross-cultural awareness
Key Requirements
Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or related field
8+ years in GMP-regulated environments
Strong working knowledge of EU, FDA, and relevant global regulations
Hands-on experience with QMS elements
Ability to lead root-cause analysis
Fluency in Japanese and strong proficiency in English