**Job Reference Number **23-MDPQDIV-16329
**Classification **Executive Level 1
**Job Title **Scientific Operations Advisor
**Division **Medical Devices and Product Quality Division
**Branch **Laboratories Branch
**Section **Laboratories Business Operations Section
**Location **Fairbairn, ACT
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$108,680 - $123,951
**Desirable Qualifications **A degree or diploma in a relevant science or engineering field
from an Australian tertiary institution or comparable overseas
qualification is desirable.
**Contact Officer Name**:Leisa Whitby
**Phone**:(02) 62892309
**Eligibility**
- To be eligible for employment with the Department of Health and Aged Care
applicants must be an Australian citizen at the time an offer of employment is made
- An applicant's suitability for employment with Health will also be assessed through a
variety of pre-employment check processes, such as:
- Satisfactory completion of an Australian Federal Police criminal history check,
and where relevant a Working with Children and Vulnerable People Check.
- Completion of a medical declaration and pre-employment medical (where
required).
- Providing evidence of qualifications.
**Division Responsibilities**
The Medical Devices and Product Quality Division (MDPQD) is part of the Health Products
Regulation Group. The division ensures Australian and international therapeutic goods
manufacturers and products meet the highest standards for quality, safety and
performance. MDPQD regulates the quality of therapeutic products for the Australian
community by: assessing medical devices, including in vitro diagnostic tests; testing and
monitoring medical devices and medicines to help ensure they continue to meet
appropriate levels of quality, safety and performance; and auditing and certifying
manufacturers against manufacturing standards so the products they produce meet
appropriate quality, safety and performance standards
**Branch Responsibilities**
The Laboratories Branch is responsible for post market monitoring and compliance testing,
investigations and reviews, as well as market authorisation assessments for therapeutic
goods. The branch conducts laboratory testing in accordance with the laboratories testing
program; lot release; provides scientific expertise to assess technical data for marketing
authorisations; provides scientific and expert advice to internal stakeholders, committees,
government etc.; and participates in the development of standards and international
collaborative activities.
**Section Responsibilities**
The Laboratories Business Operations Section provides operational support to the
Laboratories Branch by maintaining the Quality Management System, information
management, coordination of laboratory maintenance, management of the laboratory
testing program, and stakeholder engagement (including internal to the organisation,
nationally and internationally).The section also provides centralised coordination and
leadership for Laboratories Branch wide initiatives, including special projects and ongoing
business improvements, and is responsible for the management of the two WHO designated
Collaborating Centres.***
**Key Responsibilities**
The Scientific Operations Advisor works with autonomy and has responsibility for managing
a small team to provide branch wide support and facilitate the business operations,
planning and reporting functions of the TGA Laboratories Branch. This includes:
- Management of the TGA Testing Program.
- Providing scientific advice to the HPRG, broader Department and other national and
international organisations.
- Managing the TGA Laboratories Inbox.
- Facilitating External Testing.
- Initiating and maintaining strong relationships with a broad range of stakeholders.
- Maintaining the Branch's international obligations as a WHO Collaborating Centre.
- Managing and coordinating input to a range of business reports including KPI and
performance statistics reports, branch and TGA business Plans, Standard Operating
Procedures and international standards and guidelines.***
**Key Capabilities**
The successful applicant will have:
- An understanding of the regulation of therapeutic goods and the contribution of
laboratory testing to effective regulation.
- A good understanding of Quality Management Systems, in particular AS ISO/IEC
17025.
- Solid communication skills and an ability to develop and contribute clear and concise
input to a range of reports in various formats.
- High level communication and interpersonal skills with the ability to build and
maintain productive working relationships with internal and external stakeholders.
- High level organisational skills.
- Experience managing, developing and mentoring a small team.
**Minimum Requirements**
RecruitAbility is a scheme which aims to attract and develop applicants with disability and
also facilitate cultural changes in selection pan