Quality Manager, Q-Gen

4 days ago

Brisbane, Queensland, Australia Qimr Berghofer Full time

Overview
Join to apply for theQuality Manager, Q-GENrole atQIMR 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 theAPPLYbutton.
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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