About the role
AI summarisedThe Head of Quality Assurance at Takeda's Singapore biologics manufacturing facility leads the QA department to ensure product and process quality, compliance with GMP and regulatory standards, and drives continuous improvement. This role involves technical leadership, operational oversight, team development, and collaboration across global sites to support the manufacturing of life-saving medicines for rare blood disorders.
BiopharmaOnsiteQuality
Key Responsibilities
- Lead QA team to ensure robust quality oversight and compliance with regulatory, corporate, and divisional standards
- Drive implementation of quality management systems and compliance standards
- Provide leadership and technical support for all GMP/quality activities while fostering a culture of continuous improvement in quality operations
- Lead decisions on quality operation, quality risk management and product disposition
- Review and approve deviation investigation and CAPA reports
- Coordinate communication and collaboration with local and global functions
- Own, manage and control QA budget planning, forecast and execution, including OpEx, Capex and continuous improvement projects
- Lead, coach, and develop QA team, ensuring succession planning
- Lead and drive QA operational strategies
Requirements
- Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or a related discipline
- Certification and trainings such as auditor training or QP training will be advantageous
- Minimum experience of 10 years, with 5 years of supervisory position, in the pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation
- FDA/EU cGMP know-how and a thorough understanding of ICH guidelines
- Exposure to the international regulatory network
- Ability to serve as a delegate for Site Quality Head in his/her absence