Executive Level 1

4 weeks ago

Melbourne, Australia Australian Government Full time

Executive Level 1
- $111,940 - $127,670
- Fairbairn ACT, Paramatta NSW, Melbourne VIC, Brisbane QLD

Several exciting EL1 GMP Assistant Director positions available in the Therapeutic Goods Administration.

With over 90% of medicines supplied to Australia coming from overseas manufacturers, the Good Manufacturing Practice (GMP) regulation of these facilities is crucial to ensuring the quality of these goods for Australians. The GMP Clearance section assesses the GMP compliance of overseas manufacturers as well as working collaboratively with international regulatory partners on driving global GMP harmonisation and the use of inspection Reliance.

The successful applicant will initiate, establish and maintain strong relationships with a broad range of stakeholders and will exercise high level consultation skills to effectively liaise with TGA inspectors, medicine and biological module 3 evaluators, Australian sponsors, international manufacturers and regulatory partners.

The Assistant Director will also display initiative and ownership, undertake sound decision making and engage in complex problem solving in addressing technical and operational challenges. They will be accountable to contribute towards ongoing self-improvement and professional development of their teams.

**Key responsibilities include**:Working with a high degree of independence, under broad
direction in:

- Supervising and leading the operations of a team that is responsible for the
- goods manufacturers, including providing coaching and feedback, managing
- performance and building staff capability
- Implementing work plans for self and staff, including setting tasks and priorities, managing workflows, 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.
- Evaluating and managing risks in exercising appropriate delegations under the Therapeutic Goods Act 1989 and relevant legislation.
- Consulting, and liaising with industry and international agencies on technical and regulatory matters relating to the assessment and GMP approval of international medicine and biological manufacturers.
- Representing the department in a variety of forums involving internal and external stakeholders to explain the views of the agency.
- Maintaining specialist knowledge in relation to regulatory requirements and quality standards applicable to the manufacture of medicines and continuing to develop knowledge and expertise both individually and across team members.
- Contribute significantly to the development and implementation of business improvement strategies.
- Undertake other duties as directed, commensurate to the classification level of the position.

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