We are partnering with a leading Japanese MNC in Medical Devices, operating across multiple markets with strong links to a global headquarters. The business plays a critical role in advancing hospital and chronic care solutions, combining deep clinical expertise with long-term investment in innovation, integrated care models, and digital enablement. As part of the establishment of their newly created Regional HQ in Singapore, they are now looking for a senior QA/RA leader to build and lead the Quality and Regulatory function across the region.
Responsibilities
Reporting to the Regional Managing Director, the Assistant Director of QA/RA will be responsible for providing strategic leadership and operational oversight of the Quality Management System and Regulatory Affairs functions across all manufacturing facilities and Sales & Marketing offices in the region. This includes establishing, implementing, and continuously improving the corporate QMS in compliance with ISO 13485, GMP, MDSAP, and GDPMDS requirements, leading Management Review processes, and ensuring robust implementation of CAPA, change control, non-conformance management, complaint handling, and post-market surveillance systems.
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Executes manufacturing operations to perform operations including but not limited to equipment cleaning and set up as well as stream specific operations like:Upstream: Vial Thaw, Inoculation, Cell Culture and RecoveryDownstream: Chromatography, Filtration, Ultrafiltration, Final FillingCentral Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, Sampling of raw materials.
Carry out daily tasks as assigned by Lead Biotechnologist or Manufacturing Supervisor
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