The role of the Senior GMP Inspector Technical Specialist is a highly specialised technical role that performs GMP Inspections of domestic and overseas medicine manufacturers. Candidates are required to have a high degree of experience in the manufacture and/or quality assurance/quality control of medicines, including extensive practical experience in GMP. They are also required to have a proven ability to manage highly complex, non compliant manufacturing sites across diverse technical areas.

Further to this Senior GMP Inspector Technical Specialists are required to play a key role in the development of risk-based inspection strategies, in order to fully utilise available resources, in the most effective and productive manner, providing appropriate oversight of manufacturers. This risk-based strategy approach contributes to the management of the inspections workload.

The key duties of the position include:

Key capabilities:

- Extensive practical experience in applying GMP standards to inspections and compliance investigations, including complex and emerging areas.
- Proven ability to maintain and expand expertise in new technologies and evolving therapeutic goods manufacturing practices.
- Proven capability to develop, implement and refine technical standards, policies, and guidelines within the area of specialisation.
- Strong ability to identify issues, analyse complex information, and develop effective technical and regulatory solutions.
- Highly skilled in researching, evaluating, and reporting on new and emerging technologies to inform regulatory approaches.
- Highly developed communication and relationship-building skills to collaborate effectively with internal teams and external stakeholders.




- Demonstrated high-level organisational skills including the proven ability to manage competing priorities, meet deadlines, and operate effectively in high-demand environments.
- Proven ability to work collaboratively with leadership teams, provide training and mentorship, and contribute to strategic initiatives and organisational outcomes.

Desirable experience:

- Experience with international regulators / Pharmaceutical Inspection Co-operation Scheme (PICS).
- Experience in biologics/sterile/high-risk manufacturing.
- Leadership in regulatory policy or inspection frameworks.

Eligibility

- To be eligible for employment with the Department of Health, Disability and Ageing, 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 and
- Obtaining and maintaining a security clearance at the required level.

- To be eligible for role, applicants must hold a formal qualification of a degree in chemistry, biochemistry,



biology or other relevant science from an Australian tertiary institution, or comparable overseas qualification. The candidate requires extensive experience in GMP and demonstrated experience managing highly complex and non-compliant manufacturing sites across a broad range of technical disciplines.

Notes

Applications close 11:30pm AEST.

Applicants are asked to quote reference number 26-MDPQDIV-31516 to assist when making an enquiry.

This recruitment process is being used to fill both ongoing and non-ongoing positions. Non-ongoing positions will be offered on a specified term basis for an initial period of up to 12 months with the possibility of being extended (this will not exceed a total of 24 months in the same or similar role).

Getting to know the Department of Health, Disability and Ageing

The Department of Health, Disability and Ageing is focused on achieving better health and wellbeing for all Australians. If you would like to join our team, and can meet our job requirements, we invite you to apply for a position with us to build better health, better care and better quality for all Australians. The department is committed to providing an inclusive and diverse workplace where the experiences, skills and perspectives of all individuals are valued. We actively encourage applications from diverse backgrounds and cultures, so we can better represent the community we serve. The department welcomes applications from Aboriginal and Torres Strait Islander people, people with disability, mature age people, people who identify as LGBTI+, and people with parenting and/or caring responsibilities.

📌 Executive Level 2 - Senior Good Manufacturing Practice Inspector - Technical Specialist - Inspections Section (Melbourne)
🏢 Australian Department of Health Disability & Ageing
📍 Melbourne