This role is responsible for site quality compliance governance and product quality communications at Takeda's only biologics drug substance manufacturing facility in Asia
Job Summary
This role is responsible for site quality compliance governance and product quality communications at Takeda's only biologics drug substance manufacturing facility in Asia.
The incumbent will lead the self-inspection program, manage regulatory inspections, and oversee supplier qualification audits to ensure the site remains inspection-ready.
Takeda offers a stimulating career within an inclusive workplace committed to delivering better health through novel specialty pharmaceuticals.
Matching Summary
This role is responsible for site quality compliance governance and product quality communications at Takeda's only biologics drug substance manufacturing facility in Asia.
Skills & Requirements
Must-have
5-7 years pharmaceutical manufacturing experience
Regulatory knowledge EudraLex 21 CFR ICH
Lead auditor for self-inspection programs
Supplier qualification and audit management
Site quality risk management oversight
Nice-to-have
Diplomatic communication with diverse personalities
Experience with positive energy building standards
Cross-site collaboration capabilities
Senior management presentation skills
Key Requirements
University degree in Biotechnology, Chemistry, Pharmacy, Science, or Engineering
Minimum 5-7 years experience in pharmaceutical manufacturing environment
Substantial knowledge of EudraLex, 21 CFR, and ICH regulations