Regional Quality Director

Job Description : PHARMA REGIONAL QUALITY DIRECTOR MALAYSIA A leading pharmaceutical packaging manufacturer is looking for a Regional Quality Director job to provide leadership in areas of quality and manage change control processes and risk assessments in order to bring the company to the next level. This position reports to the Regional General Manager. About the Regional Quality Director Role: In this position, you will take the lead in managing and coordinating overall systems and compliance to ensure that all the standards and requirements are adhered to. Ensuring that the established protocol and QMS requirements are well implemented at all times Responsible for ensuring that the process and final products meet the customer requirements Implementing procedures and practice of ISO 13485, ISO 11607 (Part I and II), FDA, MDR, ASTM and J-GMP standards Overseeing all aspects of regulatory compliance, including product registration, market approval and post-market surveillance Overseeing the development, maintenance, and improvement of a comprehensive Quality Management system Conducting regular audits to verify compliance within established quality procedures Overseeing all aspects of regulatory compliance, including product registration, market approval and post-market surveillance Verifying, identifying, and segregating the non-conforming product detected Initiating a corrective and preventive action report Ensuring implementation of corrective and preventive action and verify their effectiveness To succeed in this Regional Quality Director role, 15 years' Quality Assurance management experience, preferably within the pharmaceutical, medical devices or packaging manufacturing industries. qualification in Science/Engineering or any related field of study 15 years' Quality Assurance management experience, preferably within the pharmaceutical, medical devices or packaging manufacturing industries Proven track record of implementing QMS programmes and managing regulatory compliance In-depth knowledge of ISO 13485, ISO 11607 (Part I and II), FDA, MDR, ASTM and J-GMP standards Strong understanding of quality management principles and continuous improvement methodologies Experience with pharmaceutical/medical devices are highly valued Excellent communication, collaboration and leadership skills Strong supervisory and hands-on skills Detail-oriented, energetic, proactive, results oriented, independent and decisive This organisation is a huge market leader within their field of expertise, and is ready for their next stage of growth.

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