Quality Manager, Q-GEN

3 weeks ago

Brisbane, Queensland, Australia QIMR Berghofer Full time
Overview

Join to apply for the Quality Manager, Q-GEN role at QIMR Berghofer.



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, Brain and Mental Health, 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.



About Q-GEN Cell Therapeutics

Q-Gen is QIMR Berghofer's TGA-licensed GMP manufacturing facility, specialising in the production of human cell therapy products for clinical trials. With a focus on regulatory compliance and manufacturing excellence, Q-Gen works with both internal researchers and external commercial partners to bring novel therapies to patients.



Responsibilities
  • Responsible for all aspects on the quality system, including maintaining TGA license for GMP manufacturing as Quality Nominee.
  • Ensure that Q-Gen's quality system is responsive to researcher and client needs, and that it supports the effective, efficient and safe manufacture of cell therapies in accordance with relevant regulations and GMP codes.
  • Manage the Q-Gen Quality Management System to ensure ongoing GMP compliance.
  • Oversee QA and QC functions including document control, CAPAs, audits, supplier management, and trend analysis.
  • Ensure product safety, effectiveness, and timely release through oversight of batch record reviews.
  • Maintain up-to-date knowledge of Australian and international GMP standards.
  • Lead internal and external audits and regulatory inspections.
  • Build and develop a high-performing quality team with a focus on collaboration and continuous improvement.
  • Ensure compliance with WHS policies and participate in facility on-call duties.


Qualifications
  • Extensive experience in GMP quality systems in a cell therapy, medical laboratory (e.g. stem cell or transplantation testing), blood services, pathology laboratory, food manufacturing, pharmaceutical manufacturing, clinical trials facility or similar setting.
  • Deep understanding of GMP principles, the Therapeutic Goods Act 1989, and codes relevant to human cellular therapy products.
  • Proven leadership and people management skills with strong emotional intelligence.
  • Strong organisational and communication abilities with a track record of managing complex projects.
  • Degree in life sciences; postgraduate qualifications and knowledge of FDA/EMA regulations are desirable.


Remuneration

Salary range is $142,044 to $149,235 plus super and generous salary packaging. This is a full-time, permanent position.



Application information

For further information: please contact


Closing Date: 26 September 2025



To submit an application: use the APPLY button. All applicants must supply the following documents: Resume and Cover letter addressing the selection criteria outlined in the Position Description.



Applicants must be an Australian Citizen, Permanent Resident or hold a valid work permit or visa. Work eligibility will be checked as part of the recruitment process.



What We Offer
  • Salary Packaging
  • State of the art facilities
  • Stimulating work setting focused on cutting edge medical research
  • Supportive and collaborative team environment
  • Parental Leave provisions


Job details
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Research
  • Industries: Research Services
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