About the role
The Quality Compliance Specialist at Takeda Singapore ensures site quality compliance governance, manages inspections and audits, and oversees product quality and compliance communications within a biologics manufacturing environment.
BiopharmaOnsiteQuality
Key Responsibilities
- Support and host regulatory inspections and communications
- Maintain inspection readiness at all times
- Lead site inspection readiness activities and self‑inspection program
- Perform supplier qualification and audits
- Participate and lead rollout of assigned Quality Systems ensuring regulatory and corporate compliance
- Report site KPIs and metrics to management
Requirements
- University degree in Biotechnology, Chemistry, Pharmacy, Science, Engineering or equivalent
- 5‑7 years experience in pharmaceutical or related manufacturing environment
- Demonstrated ability to collaborate across functions and sites
- Strong communication and diplomatic interaction skills
- Presentation skills for audits, training and senior management
- Substantial knowledge of regulatory requirements such as Eudralex, 21CFR, ICH