Regulatory Compliance Manager

1 week ago

Herston, Queensland, Australia QIMR Berghofer Medical Research Institute Full time
Manage the regulatory compliance for Q-Gen

  • Actively track and implement
  • Attractive super and salary packaging options

About QIMR Berghofer:


QIMR Berghofer is a world-leading translational medical research institute focused on improving health by developing new diagnostics, better treatments and prevention strategies, specifically in the areas of Cancer, Infection and Inflammation, Mental Health and Neuroscience, and Population Health.

Based in Herston, Brisbane and working in close collaboration with clinicians and other research institutes, QIMR Berghofer is home to more than 600 scientists, students and non-research staff.


Q-Gen Cell Therapeutics is a leading GMP manufacturing facility dedicated to the development of GMP cell therapies for use in ground breaking clinical trials.


Role Purpose / Responsibilities:

The main responsibilities are;

  • Provide expert advice on the regulatory requirements for cell therapy manufacture, dispositions and clinical trials in all relevant jurisdictions
  • Maintain detailed knowledge of existing and emerging regulations regards cell therapy manufacture
  • Ensure the quality and production systems and processes comply with all relevant legislation and codes for GMP, including the maintenance of TGA licensing for GMP manufacture
  • Assist with Batch Review and Release for Supply
  • Provide leadership in responding to regulators
  • Deputise for the Quality Assurance Manager

About you:

To be successful in this role you will need:

  • High level knowledge and expertise in GMP regulations for cell therapy manufacture in Australia, USA and Europe
  • Experience in establishing or maintaining Quality systems and associated documentation in a GMP context
  • Exceptional attention to detail and the ability to complete complex tasks in a precise and consistent manner as defined in a Standard Operating Procedure
  • Selfmotivated and highly organised; able to meet deadlines and deliver multiple competing priorities in a complex and challenging environment
  • Bachelor degree in Life Science, Medical Laboratory Science, Biomedical Engineering, Pharmacy or related discipline, or equivalent experience

Remuneration:
Salary is $98,551 p.a. to $109,419 p.a. plus super and salary packaging. This is a full-time appointment for 2 years.

Closing Date:21 May 2023

What we offer:

  • Salary Packaging
  • Bonus Superannuation
  • State of the art facilities
  • Stimulating work setting focussed on cutting edge medical research
  • Supportive/collaborative team environment
  • Parental Leave Provisions

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