Job Reference Number 22-MDPQDIV-14214

Classification Executive Level 1

Job Title Business Strategy, Support and Quality Manager

Division Medical Devices and Product Quality Division

Branch Manufacturing Quality Branch

Section Manufacturer Assessment Support Section

Location Fairbairn, ACT

Status Ongoing

Employment type Full-time

Salary Range $108,680 - $123,951

Desirable Qualifications • Qualifications and/or significant experience in Business
Analytics.

• Demonstrated experience undertaking Quality Assurance

roles, managing, and maintaining a Quality Management
System

Contact Officer Name: Paul Oosterwyk
Phone: 02 62893631
Email: paul.oosterwyk@bigpond.net.au

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) 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 Manufacturing Quality Branch (MQB) 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 (MRD), particularly on

matters relating to manufacturing practice and quality management.

Section Responsibilities

The Manufacturers Assessment Support (MAS) team supports the Branch's assessors,

inspectors and recalls officers by providing strategic and operational support on business

planning and reporting, project management, risk management, Ministerial and

departmental requests for information, internal IT Systems, data analytics and performance

reporting. Responsibilities also include strategic management of the branch Quality

Management System (QMS) and branch IT improvement initiatives, including business cases

and costings.

Key Responsibilities

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

management of MQB business planning and change management governance, co-

ordination activity (Ministerial, Executive and Departmental requests for

information), business initiatives, FOI, branch level meeting papers, performance

reporting and information processing systems.

• Responsible for the Branch-wide QMS, which is essential for maintaining our

international standing as a founding member of Pharmaceutical Inspection Co-

Operation Scheme (PIC/S), responsibilities include:

o Strategic consideration of internal and external factors affecting the QMS

o Oversight of change and document control, corrective and preventative

actions (CAPA) and deviations to our QMS undertaken by subject matter

experts in the Branch,

o Support improvement of our QMS through the scheduling and commission of

management review and internal audits

o Lead TGA’s response to, and liaison with, PIC/S audit teams during

accreditation audits, Australian National Audit Office, and internal audits

commissioned by the Department’s Corporate Assurance Branch.

• Developing and implementing work plans, setting tasks and priorities, monitoring

progress to ensure the business objectives of the team are achieved.

• Engage with external stakeholders such as Government Departments, therapeutic

good sponsors, manufacturers of therapeutic goods, peak bodies/associations, and

consumer groups to assist in the successful definition and delivery of MQB business

strategy, planning and coordination activity.

• Ensure reporting systems are in place to provide regular information updates on

operations and business initiatives.

• Supervise APS staff within the section as required

• Undertake other duties as required consistent with the EL 1 classification.

Key Capabilities

• Demonstrated experience in the management of Ministerial, Executive and

Departmental requests for information in a government regulatory and/or service

delivery environment.

• Demonstrated ability supervising and / or coordinating business planning, projects

and reporting in the public sector. Working to tight deadlines and responding quickly

to changing priorities.

• Demonstrated ability to develop and manage work plans across the life of a project.

• High-level interpersonal, negotiation and stakeholder management skills, including

the ability to develop productive working relationships with external stakeholders to

identify opportunities, facilitate cooperation and achieve outcomes.

• The capacity to acquire knowledge quickly, particularly an understanding of the

Australian regulatory framework for therapeutic goods.

• High level critical analysis and decision-making skills.

• Demonstrated ability to lead teams and supervise staff.

• The ability to work flexibly in a high-pressure environment.

• High-level written and verbal communication skills.

Desirable Experience

• Experience working with and interpreting legislation or regulatory requirements

• A degree in science from an Australian tertiary institution, or comparable overseas

qualifications.

Application Response (Single page application)

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 [NGA_GLOBAL_QUES Subject to operational

staff (remote supervision) TION|JOB(CC66DFB9- needs and organisational

2D92-4F54-A9D5- policy staff may be able to

AA0A00D454D0)] undertake a blend of office

and home based work.

16. Distance walking (ie: Large No

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 Yes [NGA_GLOBAL_QUESTION|J

vision OB(BF6242CC-0C08-4265-

BEA0-AA1500C6B10C)]

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

Description Requirement Additional Information

31. Low Lighting No

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