This role is responsible for site quality compliance governance and product quality communications at Takeda's biologics manufacturing facility in Singapore
Job Summary
This role is responsible for site quality compliance governance and product quality communications at Takeda's biologics manufacturing facility in Singapore.
The incumbent will lead inspection readiness activities, manage regulatory inspections, and oversee the site's self-inspection program as a Lead Auditor.
Takeda offers an inclusive workplace committed to delivering better health through novel specialty pharmaceuticals and patient support programs.
Matching Summary
This role is responsible for site quality compliance governance and product quality communications at Takeda's biologics manufacturing facility in Singapore.
Skills & Requirements
Must-have
5-7 years pharmaceutical manufacturing experience
Lead auditor for self-inspection programs
Knowledge of Eudralex, 21CFR, ICH regulations
Supplier qualification and audit management
Site quality risk management oversight
Nice-to-have
Diplomatic communication with diverse personalities
Experience hosting Quality Council meetings
Ability to mediate compliance expectations
Cross-functional collaboration skills
Presentation skills for senior management
Key Requirements
University degree in Biotechnology, Chemistry, Pharmacy, Science, or Engineering
Minimum 5-7 years experience in pharmaceutical manufacturing
Substantial knowledge of regulatory requirements like Eudralex and 21CFR