Executive Level 2 - Senior Good Manufacturing Practice Inspector - Technical Specialist - Inspections Section

About this role

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 efficient manner, providing appropriate oversight of manufacturers. This risk-based strategy approach contributes to the management of the inspections workload.

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.