Quality Manager, Q-gen

Lead quality systems for cutting-edge GMP cell therapy manufacturing
- Drive regulatory excellence & team leadership in dynamic clinical production
- Attractive salary packaging & superannuation 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, 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.

**Role Purpose / Responsibilities**:
Applications are invited for a skilled and motivated Quality Manager to lead the Quality Assurance and Quality Control teams at Q-Gen Cell Therapeutics. Reporting to the Operations Manager, this leadership role is critical to maintaining Q-Gen’s TGA manufacturing licence and delivering high-quality GMP-grade cellular therapies.

The following duties will apply:

- 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

**About you**:
To be successful in this position you will have:

- 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.

**Closing Date**:26 September 2025

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 focussed on cutting edge medical research
- Supportive and collaborative team environment
- Parental Leave provisions