Posted: 6 November 2023
Closes: 22 November 2023
The Opportunity
Are you a talented Quality Systems Manager with expertise in vaccines, diagnostics, or therapeutic product development? Would you like to join a values driven, not-for-profit organisation with a meaningful mission? Then this could be the role for you!
This position will join our innovative Burnet Diagnostics Initiative (BDI) group to direct the development, implementation and administration of Burnet’s quality management systems, including the BDI under ISO9001. You will be the primary contact for all external bodies on quality related matters and will recommend to the organisation specific activities and resources required to support the development of in-vitro diagnostic products to the highest quality standards.
In this role, you will:
- Develop and implement quality assurance and regulatory strategies for the BDI to ensure compliance with international Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) and ISO9001 certification
- Direct and oversee the implementation of quality systems in other relevant Burnet teams
- Direct the internal auditing function to ensure that the operations of all functional groups are compliant
- Represent the Burnet teams and its affiliates’ interactions with external organisations including Customers and Contract manufacturers, the TGA or other regulatory bodies; serve as a primary contact during all audits and approve responses to audit reports
- Serve as an external approver to review and sign off on online laboratory notebooks and ensure all data is being logged and captured correctly
- Effectively manage and develop two Quality Assurance Specialists
Refer to the attached position description for full details. This is a full time, ongoing contract. Part time working from home is offered and you will have flexibility to manage your own hours.
Let’s talk about you
The following criteria are essential requirements:
- Bachelor’s degree in life science or engineering
- Minimum 5 years of experience working in a senior quality role
- Significant managerial experience in a quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g., ISO 9001, ISO 13485 or GMP)
- Significant experience in vaccines and/or diagnostics and/or therapeutic product development from preclinical to clinical stages and knowledge of quality and/or regulatory requirements
- Laboratory quality management, audit and accreditation expertise (NATA training in GLP)
- Demonstrated experience managing, supporting, and developing staff
- Practical experience in project management tools and systems
- Excellent relationship management and communication skills
- Demonstrated capacity to work independently, exercising strong judgment, decision making and problem-solving skills
Awareness of occupational health and safety and risk management issues in a range of settings is also preferable but not essential.
The Burnet experience…
We want you to have a successful and meaningful career at Burnet and are committed to providing a supportive workplace environment for all our people. You will be part of a collaborative culture where progressive leadership, innovation, respect, and excellence are valued. Join a team of talented individuals who are passionate about what they do – achieving a more equitable world through better health.
We offer:
- A monthly accrued day off for full-time staff
- 14 weeks paid parental leave
- Flexible working arrangements
- Generous salary packaging
- Opportunities for career and professional development
Who are we?
Burnet Institute is a leading Australian, unaligned, not-for-profit, organisation passionate about social justice, equality and evidence-based research.
Burnet Institute brings together a highly diverse skill base, with more than 400 staff and students working across cutting-edge research and projects to address some of the most relevant global health issues. Institute-wide interdisciplinary health programs Disease Elimination, Health Security and Pandemic Preparedness, and Maternal, Child and Adolescent Health are at the heart of our daily decision making. Harnessing our international and local field presence, our laboratories, and our mixed development and research cultures drives a greater focus on the most relevant health issues and achieves a greater impact as a result.
Whilst our headquarters is in Melbourne, Australia, we also have offices in Papua New Guinea and Myanmar, and are actively involved in research and public health programs throughout Australia, the Asia-Pacific region and Africa. Burnet is the only unaligned organisation in Australia that has dual accreditation with both the Australian National Health and Medical Research Council (NHMRC) and the Department of Foreign Affairs and Trade (DFAT).
Bring your whole self to work
At Burnet, we foster a diverse and inclusive culture. We want our people to feel like they belong and are free to be themselves at work. We have an active Gender Equity, Diversity & Inclusion (GEDI) Council that works to promote and improve gender equity, diversity and inclusion across the Institute, by developing and implementing strategies informed by both national and international best practice and staff input. Burnet holds an Athena SWAN Institutional Bronze Award from Science in Gender Equity (SAGE). If you have a reasonable adjustment, support, or access requirement at any stage of the recruitment process, we encourage you to let us know by emailing careers@burnet.edu.au.
Sounds great! How do I apply?
Apply below and attach the following documents:
- Resume
- Cover Letter
Applications close at 11:59pm AEDT on Wednesday, 22nd November 2023.
As part of our commitment to gender equity, we have included a question in the application process on gender. This will allow us to monitor and report on gender in relation to our recruitment process.
Burnet is a child safe organisation. The successful applicant will be required to apply for a National Police Check and/or Working with Children. Current Australian working rights are required for all applicants.
Find out more and apply here.
