Director

The Office of the Gene Technology Regulator (OGTR) protects the health and safety of people and the environment by identifying and managing risks posed by, or as a result of, gene technology, by regulating certain dealings with genetically modified organisms (GMOs).

As the Director of the OGTR Monitoring and Compliance team you will work as part of a dynamic team and play an important role in ensuring dealings with GMOs are conducted according to risk management requirements.

Monitoring, auditing and inspections occur across agricultural field trial sites, clinical settings and within contained research facilities. The section monitors compliance with conditions of licences, authorisations or other instruments and restrictions, and manages risks in relation to any potential breach of conditions. The section also undertakes monitoring activities for the Security Sensitive Biological Agents scheme under the National Health Security Act 2007 and audits for the World Health Organization Global Action Plan for Poliovirus Containment.

Key responsibilities:

• Leading, supervising and managing the operations of a team that is responsible for monitoring, auditing and compliance activities, in the context of scientific and technical regulation.
• Implementing work plans for monitoring inspections and audits, including setting tasks and priorities, managing workflows, directing and coordinating quality outputs and ensuring key performance indicators and targets are achieved.
• Applying robust decision making and judgement, including research and analysis in assessing situational and documentary information associated with inspection outcomes.
• Providing high level scientific, technical and regulatory advice to internal and external stakeholders on complex regulatory issues relating to compliance with the relevant legislation.
• Evaluating and managing risks in exercising appropriate delegations and compliance powers under the relevant legislation.
• Representing the office in a variety of forums involving internal and external stakeholders
• Undertaking frequent travel as part of a small team, sometimes at short notice, to rural and urban locations around Australia is essential.

Key capabilities:

• The ability to apply conceptual, strategic and analytical skills to complex problems in a scientific and regulatory context.
• Demonstrated ability to make high impact decisions based on sound professional judgement and evaluating and managing risks in a scientific regulatory context.
• High level communication skills and an ability to liaise, engage and collaborate with a diverse range of internal and external stakeholders to build relationships and exercise regulatory powers for operational and strategic outcomes. 
• An exceptional results orientation based on leading by example, including determining and being accountable for objectives and priorities, and supporting a positive culture and building staff capability.
• Ability to lead, develop and implement strategies in relation to change management and business improvement activities.

Desirable qualifications and experience:

• A tertiary qualification in a relevant field of science, e.g., chemistry, biochemistry, microbiology, biotechnology, or pharmacy from an Australian tertiary institute or equivalent overseas qualification.
• Certificate IV Government Investigations, or equivalent, or the ability to attain this qualification within 12 months of employment.
• Extensive experience (at least three years) leading and managing a monitoring/auditing team relevant to biological sciences and biosafety.

• 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 (where required), and  
  • Obtaining and maintaining a security clearance at the required level.  
• For this role applicants must be able to obtain and maintain a Negative Vetting 1 security clearance within 4 months of employment or hold a current security clearance at an appropriate level. 
• For this role applicants must hold a current Australian driver’s licence, and at least three years’ experience in regulatory monitoring and auditing for compliance relevant to biosafety including clinical trials, medical, research, agricultural or related environments.

• Applications close 11:30pm AEDT.
• Applicants are asked to quote reference number 26-OGTROGTRDIV-32016 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).