Quality & Risk Manager – National Reference Laboratory
Australia, Victoria
Full Time
15/09/2020
  • Be a Part of an Executive Team and Drive Quality
  • Work with Highly Engaged and Passionate Scientists
  • Ensure Quality of all Services are Exemplary, Lead and Motivate your Team

 

CLIENT

Our client is part of a not-for-profit, highly respected Biomedical Research Facility with more than 170 staff, based near Melbourne’s CBD. A Division within this organisation is the National Reference Laboratory (NRL). With a work-force of over 30 scientific personnel, NRL works to improve the accuracy of testing for infectious diseases by laboratories and in point-of-care  settings in Australia and internationally.

Established as a not-for-profit scientific organisation as part of the Australian Government’s HIV and AIDS strategy in 1985, NRL is contracted by the Department of Health and licensed by the Therapeutic Goods Administration (TGA). It collaborates with scientific partners worldwide to assure the quality of testing for the diagnosis and management of human communicable diseases, including but not limited to HIV, HCV, and HTLV.

NRL does this by providing specialised products and services, including pre- and post-market evaluations of test kits; provision of quality assurance programs to laboratories; highly specific and non-routine testing services; consultation, education and training for laboratories. These services are provided globally.

 

THE ROLE

This position is accountable for three areas of NRL: Quality,  Risk, and Safety Management.

As both a TGA licensed and NATA accredited facility, the successful candidate will ensure all aspects of the NRL’s Quality Management System (QMS) relating to NATA, ISO 9001, ISO 15189, GMP & AS 4801 are maintained, further developed, and implemented.

In addition to being the primary contact person for all QMS-related activities, you will also be the NRL’s management representative responsible for safe work practices and staff safety.

As all other NRL roles, the Quality & Risk Manager role is an initial fixed-term three-year renewable contract.

Some of your responsibilities will include:

  • Manage the development, implementation, and maintenance of NRL’s QMS in accordance with ISO 9001, AS 4801, GMP, TGA license for compliance with the Code of Good Manufacturing Practice NATA, ISO 15189 & 17043.
  • Ensure all relevant policies and procedures are updated, available, and fit for purpose
  • As a Quality Manager, provide advice to staff across the organisation relating to improvements of internal practices and policies
  • Prepare and host all activities related to external audits, conduct root cause analysis to identify corrective actions, and respond to audit findings in a timely manner
  • Develop and deliver quality training courses for internal staff and for WHO-related or capacity building consultancies on an international level as required
  • Lead NRL’s risk management framework, co-ordinate risk assessments, reviews, and management planning
  • Assess, report, and manage strategic and operational risks
  • As a part of the Executive Team, contribute to strategic, business, and operational planning, management review, and reporting requirements
  • Together with the Health & Safety Advisor, ensure NRL complies with the best safe work environment practices
  • Actively support and mentor staff, lead by example and engage people in quality using your excellent people-influencing skills
  • Establish and maintain processes to support regulatory affairs activities supporting different products and services

 

SELECTION CRITERIA

To be short-listed for this responsible role, you will need to meet the following criteria:

  • Tertiary scientific qualification of at least Masters level, preferably in virology or cell biology
  • Detailed knowledge of infectious diseases testing, including standards and regulations relating to QC testing and/or manufacturing procedures
  • Previous QA experience working in a laboratory environment within infectious disease testing or manufacturing environment
  • Proven leadership experience within a management role responsible for quality systems maintaining compliance with TGA, NATA, GMP, relevant ISO standards, and AS 4801
  • Open and transparent management style, with the ability to empower and mentor staff
  • Excellent stakeholder engagement and relationship building skills
  • Self-motivated with outstanding communication skills and passion for diagnosis and management of infectious human diseases

To be considered you shall be required to provide evidence you have permanent working rights in Australia or hold a relevant working visa to work full-time hours.

 

APPLICATIONS

Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter addressing your suitability for this role, in Word Format.

To discuss this unique and exciting opportunity please call Jo on 0411 197 171.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we cannot contact all candidates.  Please note, if you are not successful on this occasion, your resume will remain on our database and you may be contacted for other similar roles in the future.