About the Company
Cell Therapies Pty Ltd (CTPL) is a commercial Contract Development and Manufacturing Organisation (CDMO) located within the Peter MacCallum Cancer Centre. We specialise in the development and delivery of cell and gene therapies and have more than 20 years’ experience in this area.
The growth of CTPL will continue through our commitment to supporting both Australian and international research and development activities, alongside delivery of commercial contracts to provide these highly personalised therapies to patients in Australia and the region.
About the Role
We are seeking a motivated Quality Assurance Manager to join our growing team.
In this role, you will lead day-to-day Quality Assurance operations, ensuring our manufacturing and distribution activities meet GMP requirements for clinical and commercial cell therapy products. Working closely with cross-functional teams, you will provide quality oversight across manufacturing activities, support batch review and product release, and drive continuous improvement of our Quality Management System.
You will also lead and mentor a small QA team while collaborating with internal stakeholders and external clients to ensure quality, compliance and timely delivery of critical therapies.
This is a full-time position located at our new, state-of-the-art Melbourne facility, located at the Peter MacCallum Cancer Centre on the edge of the CBD in Australia’s most dynamic biomedical precinct. This is a great opportunity to gain experience and get directly involved in the newest advanced therapies that can make a serious impact on patient’s lives.
What you will be expected to do
- Lead day-to-day Quality Assurance activities supporting GMP manufacturing operations
- Provide QA oversight and guidance on manufacturing and technical quality matters
- Oversee and maintain key elements of the Quality Management System, including deviations, CAPA, change control, supplier management and internal audits
- Support batch record review and release of clinical trial and commercial products
- Monitor and review quality metrics
- Manage and develop a team of QA professionals, supporting their development
- Act as a key point of contact for QA matters with internal stakeholders and external clients
- Contribute to maintaining a strong culture of quality, safety and compliance across the organisation
Skills & Experience
Essential
- Tertiary qualification in Life Sciences
- At least three years of experience in a senior QA or manufacturing role
- Strong knowledge of GMP principles, particularly within clinical or commercial manufacturing
- Demonstrated ability to make sound, risk-based quality decisions
- Strong communication and stakeholder engagement skills
- Highly organised with the ability to manage multiple priorities in a fast-paced environment
- A proactive, quality-focused mindset and strong attention to detail
Desirable
- Experience working with biologics, cell therapy or advanced therapy manufacturing
- Experience leading a team of direct reports
- Understanding of GMP manufacturing operations and cross-functional processes
- Experience working in a CDMO environment and interacting with external clients
At CTPL we are passionate about the work we do but equally passionate about our people. We want everyone to bring their true self to work. We support the wellbeing of our staff through mindfulness sessions, continuous improvement activities and 5 wellness days a year.
The salary offered will be commensurate with skills, experience and industry standards.
If you believe you are a great fit, please apply now.
You will be directed to our recruitment portal to complete the application process.
*We will not be liable for any fees and cost associated with unsolicited CVs sent to us from recruitment agencies.
For additional information please see our website at www.celltherapies.com
Right to live and work
You must have the right to live and work in this location to apply for this job.
To apply for this job please visit celltherapies.readycareers.io.
