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Quality Assurance (QA) Manager

  • 2024-34834
  • Sydney, Australia
  • Quality and Regulatory
  • Hybridarbeit

We currently have an excellent opportunity for a Quality Assurance (QA) Manager to support our Pacific business, based in Sydney.

 

Reporting to the Quality Manager, Asia Pacific, you will be responsible for maintaining and optimising Bio-Rad’s quality management system. You will support the commercial organisation for audit programs; maintain controlled substances /drug licenses/Authorisation and execute operation control on the release of controlled substances/drug products. You will also support import/export  documentation such as coordinating of CITIES, Biosecurity certificates and/or poison licenses /permits to support our Pacific distribution centre operations.

 

How You’ll Make an Impact: 

  • Facilitate timely corrective actions, failure analysis, and Quality Assurance initiatives.
  • Collaborate with various departments to develop, review, and update local policies, procedures for processes, ensuring alignment with Global and ISO standards.
  • Drive improvements in internal and external quality metrics in support of strategic objectives and ISO certification maintenance.
  • Support the complaint handling system of both regulated and non-regulated products based on global complaint handling policy.
  • Proactively manage audits and inspections and assessment activities ensuring adherence to quality standards and requirements.

 

What You Bring:  

 

  • Minimum bachelor's degree in science, medical science or equivalent. Internal auditor qualification preferred.
  • At least 7 years' work experience in Quality Assurance with 2 years supervisory/management experience. Extensive experience in ISO9001, ISO 13485, &/or GMP.
  • Strong planning/organizing skills/attention to details
  • Staff management skills and proactive approach to resolving issues
  • Work passion with positive thinking and capable of inspiring a culture of quality and continuous improvement across all levels of the organization
  • Good oral and writing English
  • Strong ability on management of work pressure
  • Excellent interpersonal communication skills

 

If you have experience that aligns with the responsibilities of this role, we encourage you to apply. 

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. 

  

Benefits: Bio-Rad's biggest asset is its people, and our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We are proud to offer a variety of options, including salary packaging options including novated leasing, extensive learning and development opportunities, education benefits, employee assistance program for all employees and their immediate families and insurance offerings with our default superannuation fund.  

  

EEO Statement: Bio-Rad is an Equal Employment Opportunity employer, and we welcome candidates of all backgrounds. People with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.  

  

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorised to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.  

 

#LI-DN1 

 

Legal Entity: (AUS_3012)Bio-Rad Laboratories Pty Ltd

 

 

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