Location
Singapore
Department
Quality
Posted
4 days before
About This Role
Takeda seeks a Senior Quality Compliance Specialist in Singapore to govern site quality compliance and manage product quality communications for their biologics manufacturing facility. This role ensures adherence to strict regulatory standards.
Responsibilities
- Manage regulatory inspection and audit readiness activities.
- Lead self-inspection programs and perform supplier qualifications/audits.
- Drive Quality System rollout and maintain compliance with corporate requirements.
- Report site KPIs and manage the Site Quality Risk Register.
- Handle product quality communications, including complaint investigations and recalls.
- Host and manage monthly Quality Councils meetings.
Requirements
- University degree in relevant sciences (Biotech, Chem, Pharm, etc.).
- 5-7 years in Pharmaceutical manufacturing environment.
- Demonstrated cross-functional/cross-site collaboration ability.
- Strong knowledge of regulatory requirements (Eudralex, 21CFT, ICH).
- Excellent communication and presentation skills.
- Proven problem-solving abilities.