Senior Quality Assurance Manager
21 hours ago
We are seeking an experienced Senior Quality Assurance Manager to support our Pacific business, based in Sydney. The successful candidate will report to the Quality Manager, Asia Pacific and be responsible for maintaining and optimising Bio-Rad's quality management system.
The ideal candidate will have a strong background in Quality Assurance with experience in ISO 9001, ISO 13485, and/or GMP. They will be responsible for supporting the commercial organisation for audit programs; maintaining controlled substances/drug licenses/Authorisation and executing operation control on the release of controlled substances/drug products.
The Senior Quality Assurance Manager will also support import/export documentation such as coordinating CITIES, Biosecurity certificates and/or poison licenses/permits to support our Pacific distribution centre operations.
This is a challenging role that requires the ability to facilitate timely corrective actions, failure analysis, and Quality Assurance initiatives. The successful candidate will work collaboratively with various departments to develop, review, and update local policies, procedures for processes, ensuring alignment with Global and ISO standards.
Key responsibilities include driving improvements in internal and external quality metrics in support of strategic objectives and ISO certification maintenance. The Senior Quality Assurance Manager will also support the complaint handling system of both regulated and non-regulated products based on global complaint handling policy.
A key aspect of this role is proactively managing audits and inspections and assessment activities ensuring adherence to quality standards and requirements.
To be successful in this role, you will need to have a minimum bachelor's degree in science, medical science or equivalent. Internal auditor qualification is preferred, along with at least 7 years' work experience in Quality Assurance with 2 years supervisory/management experience. Extensive experience in ISO 9001, ISO 13485, &/or GMP is highly desirable.
The salary for this position is estimated to be around $AUD120,000 - $AUD150,000 per annum, depending on experience. If you have a passion for quality and a proven track record in Quality Assurance, we encourage you to apply.
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Senior Quality Assurance Engineer
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