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June

Executive Level 1 - Compliance Strategy Team Leader

National Health Funding Body - Barton, ACT

Biotech, R&D, Science
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

Full Job Description
Job Reference Number 21-MDPQDIV-8604
Classification Executive Level 1
Job Title Compliance Strategy Team Leader
Division Medical Devices and Product Quality Division
Branch Manufacturing Quality Branch
Section Licensing and Compliance Strategy Section
Location Woden, ACT
Status Ongoing
Employment type Full-time
Salary Range $104,562 - $119,255 per annum
Mandatory Qualifications Tertiary qualifications in a relevant discipline from an Australian

tertiary institution or equivalent overseas institution.
Contact Officer Name: Katherine Clark
Phone: 02 6289 3615
Email: Katherine.Clark@health.gov.au

Eligibility
To be eligible for employment with the Department of Health 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
evaluation of applications to approve new medical devices (including in vitro devices, IVDs)
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, tissue and cellular therapies, 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
The Licensing and Compliance Strategy Section has responsibility for GMP licence
application management, inspection coordination and assessment of GMP compliance
signals. These include application review, scheduling of on-site inspections, issuing GMP
licences and certificates, assessing and managing compliance signals, and liaising with
overseas regulatory agencies on the inspection of therapeutic goods manufacturers.

Key Responsibilities
The Compliance Strategy Team Leader is responsible for applying a data driven approach
within the regulatory environment.

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.

The role is responsible for leading a GMP compliance team that is responsible for the
triaging and analysis of GMP manufacturing non-compliance signals for domestic and
foreign manufacturing sites as well as GMP licence and certification applications.

The role has operational oversight and decision making on the assessment of non-
compliance signals and contributes to the decision making for regulatory decisions and
scheduling onsite GMP inspections.

Key Capabilities

Applicants are required to demonstrate:
  • Proven ability to make high impact decisions based on sound professional judgement
and evaluating and managing risks.

  • 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.

  • Ability to develop and implement strategies in relation to change/business
improvement activities.

Desirable qualifications
  • Experience or understanding of the regulation of therapeutic goods in Australia,
including the provisions relevant to the quality control/quality assurance or
manufacture of therapeutic goods.

  • Experience in interpreting statutory provisions.
  • Strong investigative, analytical and research skills.
  • Excellent communication, negotiation and liaison skills and a demonstrated
commitment to maintaining and improving client services with both internal and
external stakeholder groups

  • Sound experience in supporting teams of professionals in Australian government
regulatory, legal or compliance environments.

  • Well-developed written communication skills and strong attention to detail.
  • Strong attributes of integrity and equality.
Desirable Experience
  • Qualifications or training in regulatory compliance by a Commonwealth or State law
compliance or enforcement agency would be highly desirable (eg. Certificate IV -
Government Investigation/Compliance).

  • Sound knowledge of the legislation and policy frameworks relevant to the regulation
of therapeutic goods, including knowledge and experience in the application of the
Manufacturing Standards and Therapeutic Goods Act 1989

  • Well-developed interpersonal, communication and liaison skills.
  • Recent experience with IT systems, such as Microsoft Office, Lotus Notes
applications, TRIM electronic document management and Microsoft Dynamics 365.

Application Response
Your application will be assessed on your ability to demonstrate that you possess, or have
the real potential to develop, the required skills, knowledge, experience and qualifications
to perform the role. These requirements are based on the information provided to you as
part of the job advertisement, in line with the APS Work Level Standards.

Applicants are required to provide a statement of claims framed around the key duties and
key capabilities. Your statement of claims should be no more than one page in total with a
font no smaller than size 10. Applications that do not meet these requirements may not
be considered.

Work Environment Description
Responsibilities - As detailed in Section 28 of the Work Health and Safety Act 2011 while at

work, a worker must:
  • Take reasonable care for his or her own health and safety
  • Take reasonable care that his or her acts or omissions do not adversely affect the
health and safety of other persons
  • Comply, so far as the worker is reasonably able, with any reasonable instruction that
is given by the person conducting the business or undertaking to allow the person to
comply with this Act

  • Cooperate with any reasonable policy or procedure of the person conducting the
business or undertaking relating to health or safety at the workplace that has been
notified to workers

  • Complete all WHS related induction and training
  • Report all work related incidents and/or illnesses to the WHS Section
Description Requirement Additional Information

Administrative

1. Computer Use Yes

2. Generic screen based Yes

3. Sitting at desk Yes

4. Standing for long periods No

Manual Handling

5. Lifting 0-15kg No

6. Lifting 15 kg + No

7. Climbing No

8. Bending No

9. Squatting No

10. Reaching No

11. Push/pull No

12. Sequential Repetitive No
Movements in short period of time

13. Manual dexterity/manipulation No

Work Environment

Description Requirement Additional Information

14. Work with others towards Yes
shared goals in a team environment

15. Works in isolation from other Yes
staff (remote supervision)

16. Distance walking (ie: Large Yes
building or inter-building transit)

17. Works outdoors No

18.Works in a call centre No
environment

19. Works in a customer service No
environment

Tasks Involving

20. Exposure to chemicals No

21. Exposure to biological hazards No

22. Working at heights No

23. Requirement to wear personal No
protective equipment (PPE)

24. Requirement for full Colour No
vision

25. Work with energetics and No
explosives

26. Exposure to Petrol, Oil, Lubricant No
Products that may cause
dermatological conditions

27. Exposure to extreme No
temperatures

28. Confined spaces No

29. Exposure to Non-ionising No
radiation

30. Excessive Noise No

31. Low Lighting No

Description Requirement Additional Information

32. Dangerous Goods/ Equipment No

33. Exposure to airborne odours No

Travel

34. Frequent travel - Vehicle No

35. Frequent travel - Aeroplane No

36. Frequent travel - Seaborne No

Cyclic Workload

37. Peaks & Troughs Yes

38. Frequent Overtime No

39. Rostered Shift Work No