Executive Level 1

**Job Reference Number **22-MDPQDIV-14568

**Classification **Executive Level 1

**Job Title **GMP Assistant Director

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **Clearance Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$108,680 - $123,951

**Highly Desirable **A tertiary qualification in a relevant field, e.g., chemistry,
**Qualifications **biochemistry, microbiology, biotechnology, pharmacy or

engineering from an Australian tertiary institute or equivalent
overseas qualification.***

**Desirable Qualifications **Applicants who do not have a tertiary qualification in the above
fields, but with demonstrated knowledge and experience in the
manufacture of therapeutic goods, and/or experience working
in a regulatory environment relevant to the manufacture of
therapeutic goods may also be considered.

**Contact Officer Name**:Stephen Farrell - Director GMP Clearance
**Phone**:02 6289 3619

**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 (HPRG). The Division evaluates, monitors and tests the quality of

medicines and medical devices approved for supply in Australia, and works to ensure

Australian and international therapeutic goods manufacturers meet specified standards.

**Branch Responsibilities**

The Manufacturing Quality Branch works to ensure manufacturers of medicines, as well as

blood, tissue and cellular therapies, meet appropriate quality standards. This involves both

the physical and/or remote inspection of manufacturing facilities in Australia and abroad as

well as provision of clearances for facilities where suitable inspections have been carried out

by comparable overseas regulators and where necessary, initiation of appropriate

regulatory action to ensure compliance with the quality standards.

The branch also coordinates product recalls when necessary and provides technical advice

to support decisions made by the Medicines Regulation Division, particularly on matters

relating to manufacturing practice and quality management.

**Section Responsibilities**

Over 90% of medicines supplied to Australia are manufacturer overseas. The GMP Clearance

manufacturers incorporating GMP inspection information from comparable international

regulators in addition to a range of manufacturing documentation. Additionally, the section

is responsible for managing the broader GMP Inspection Reliance framework which includes

collaboration, assessment and maintenance of international agreements and arrangements.***

**Key Responsibilities**

The successful applicant will initiate, establish and maintain strong relationships with a

broad range of stakeholders and will exercise high level consultation skills to effectively

liaise with TGA inspectors, manufacturers and Australian sponsors of therapeutic goods.

This role includes working with a considerable degree of independence and as part of a

clearances.

The Assistant Director will also display initiative and ownership, undertake sound decision

making and engage in complex problem solving in addressing technical and operational

complexities. They will be accountable to contribute towards ongoing self-improvement and

professional development of their work area.

Key responsibilities include: Working with a high degree of independence, under broad

direction in:

- Supervising and leading the operations of a team that is responsible for the

goods manufacturers, including providing coaching and feedback, managing

performance and building staff capability
- Implementing work plans for self and staff, including setting tasks and priorities,

managing workflows, monitoring progress, directing and coordinating quality

assurance practices to ensure quality outputs and ensuring key performance

indicators and target timeframes are achieved.

related inquiries consistent with applicable regulatory requirements and principles of

best practice regulation.
- Providing high level technical, regulatory and policy advice to internal and external

stakeholders on complex regulatory issues relating to the manufacture of medicines.
- Evaluating and managing risks in exercising appropriate delegations under the

Therapeutic Goods Act 1989 and relevant legislation