Executive Level 1

**Job Reference Number **23-MDPQDIV-16331

**Classification **Executive Level 1

**Job Title **Laboratory Manager

**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

**Mandatory Qualifications **A degree or diploma in a relevant science or engineering field
from an Australian tertiary institution or other comparable
qualification or relevant experience.***

**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**
- Provide technical leadership, direction and coordination to scientific sections across

the Branch including ensuring compliance of all activities with ISO 17025

accreditation
- As the decision maker and financial delegate, manage the procurement of

equipment, instruments and consumables for laboratories across the Branch***
- Manage the calibration, service, and maintenance of laboratory equipment

programs, including coordinating and managing staff responsible for undertaking

these duties
- Oversee quality system activities, including scheduling testing of equipment and

analytical instrument calibrations, performing user checks and associated technical

administration, reviewing and updating technical documentation, and maintaining

training records, ensuring compliance with ISO17025 accreditation requirements
- Direct and coordinate technical activities of the laboratory to ensure services are

adequate and meet the needs of analysts and technicians
- Review and approve procedures for specific items of equipment, ensure standard

operating procedures are updated, for example, in relation to equipment calibration

or building services
- Contribute to internal audits and implement / address corrective and preventative

actions***
- Act as a central point of contact with facilities managers / providers for major capital

works***
- Manage complex and critical capital equipment procurements
- Manage and lead the Branch On Call Officers group responsible for ensuring

appropriate management of the laboratory facilities during after-hours emergencies***
- Ensure the laboratory complies with relevant accreditation requirements (e.g. OGTR

and ISO)
- Maintain relevant permits and licences
- Perfo