Executive Level 1

**Job Reference Number **22-MDPQDIV-15467

**Classification **Executive Level 1

**Job Title **Inspection Coordination Team Leader

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **Licensing and Compliance Strategy Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

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

**Desirable Qualifications **A tertiary qualification in science such as chemistry,
biochemistry, microbiology, biotechnology, pharmacy or
engineering from an Australian tertiary institute or equivalent
overseas qualification.

**Contact Officer Name**:Katherine Clark
**Phone**:(02) 6289 3615

**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 responsible for undertaking
for supply in Australia. It is also responsible for the ongoing monitoring of medical devices to
ensure they meet the necessary standards throughout their lifecycle. The Division also
works to ensure Australian and international therapeutic goods manufacturers meet
specified standards and provide laboratory services.

**Branch Responsibilities**

The Manufacturing Quality Branch (MQB) is responsible for ensuring manufacturers of
medicines as well as blood and biologicals, meet appropriate quality standards. This involves
both the physical 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. The branch also coordinates product recalls when
necessary and provides technical advice to support Medicines Regulation Divisions
decisions, particularly on matters relating to manufacturing practice and quality
management.

**Section Responsibilities**

management, inspection coordination and assessment of GMP non-compliance signals.
and certificates, assessing and managing compliance signals, and liaising with overseas
regulatory agencies on the inspection of therapeutic goods manufacturers.

**Key Responsibilities**

The successful applicant will lead a team with a critical role in ensuring we maintain our
GMP inspection program, coordinating sponsor requirements for inspections and ensuring
that we meet the TGA cost recovery requirements.

This role includes working with a considerable degree of independence and as part of a
- Apply, implement and oversee the use of government and departmental financial

business rules relating to travel including authorising / recommending the approval
of financial outputs associated with fees and charges relating to inspections,
including travel reconciliation and refunds;
- Uphold the requirements of the Work Health and Safety Act 2011, including

reporting on matters in relation to work health safety (WHS) and undertaking risk
assessments and itinerary planning relating to travel, in collaboration with
nominated Inspectors and the Department’s security advisors;

certificates. and related enquiries consistent with applicable regulatory
requirements and principles of best practice regulation.
- Provide high level technical, regulatory and policy advice to internal and external

stakeholders on complex regulatory issues relating to the manufacture of medicines
and biologicals.

**Key Capabilities
- Proven experience in working with considerable independence and managing a

team, including providing coaching and feedback, managing performance and
building staff capability.
- High level communication skills and an ability to liaise, engage and collaborate with a

diverse range of internal and external stakeholders to achieve outcomes and
facilitate cooperation for operational and strategic initiatives.
- Proven ability to make high impact decisions based on sound professional judgement

and evaluating and managing risks.
- Ability to develop and implement strategies in relation to change/business

improvement activities.
- Expert knowledge and experience in the regulation and/or manufacture of

therapeutic goods.

**Minimum Requirements**

RecruitAbility is a scheme which aims to attract and develop applicants with disability and
also facilitate cultural changes in selection panels and agency recruitment. All vacancies for
the Department of Health and Aged Care are advertised under the RecruitAbility Scheme.
Job applicants with disability who:

- op