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Executive Level 1

4 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-18035

**Classification **Executive Level 1

**Job Title **Compliance and Enforcement Team Leader

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **GMP Operations and Strategy Section

**Applications open date **Wednesday, 31 May 2023

**Applications closing date **Wednesday, 21 June 2023

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$111,940 - $127,670

**Mandatory Qualifications **A tertiary science qualification 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 a 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) assists in the timely supply of therapeutic goods,
ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on
assessing manufacturers' compliance with Good Manufacturing Principles for medicines,
blood, tissues and cellular therapy products and conducting product recalls for all types of
therapeutic goods. MQB also has responsibility for TGO 93 and quality of medicinal cannabis
products.

**Section Responsibilities**

inspection coordination and GMP regulatory reforms. The section has teams responsible for
issuing GMP licences and certificates, investigating compliance signals and undertaking
enforcement actions. In addition, the section supports the branch by providing strategic and
operational support in relation to regulatory reforms, business planning and Ministerial and
departmental requests for information, systems, data analytics and performance reporting.

**Key Responsibilities**

The Compliance and Enforcement Team Leader supervises and leads a compliance team
responsible for the triaging and analysis of GMP manufacturing non-compliance signals for
domestic and foreign manufacturing sites. The role has operational oversight and decision
making on the assessment of non-compliance signals and contributes to the decision making
for regulatory decisions.

research and analysis in assessment of GMP compliance signals and related inquiries
consistent with applicable regulatory requirements and principles of best practice
regulation.

applicable manufacturing and quality standards to case manage compliance issues.

The key responsibilities include working with a high degree of independence, under broad
direction in:

- Leading a compliance team responsible for the triaging and analysis of GMP

manufacturing non-compliance signals for domestic and foreign manufacturing sites.
The role has operational oversight and decision making on the assessment of non
- compliance signals and contributes to the decision making for regulatory decisions.

assessment of GMP compliance signals and related inquiries consistent with
applicable regulatory requirements and principles of best practice regulation.
- This position has a key role in building the data analytical capacity to further the

progress in using a data based approach for our risk based inspection program and in
planning the compliance strategy.
- Implementing work plans for self and staff, including setting tasks and priorities,

managing work flows, monitoring progress, directing and coordinating quality
assurance practices to ensure quality outputs and ensuring key performance
indicators and target timeframes are achieved.
- Providing 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**

Applicants are required to demonstrate:

- Expert knowledge and experience in quality control/quality assurance or

manufacture of therapeutic goods.
- Proven ability to make high impact decisions based on sound professional judgement

and evaluati

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