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quality manager
2 weeks ago
Organisational Context
LifeStrands Genomics Australia is a NATA and CAP accredited molecular laboratory that specialises in cancer genomics.
Recognising the growing need for cancer genomics and prevention, LifeStrands Genomics Australia was established in Melbourne with a focus on oncology research and advanced genetic testing. We believe that everyone should have access to better healthcare through advancement in clinical genomics.
About you
We're looking for a Quality Manager with a solid grasp of laboratory quality systems and regulatory compliance. This role requires hands-on experience with electronic Quality Management Systems (QMS), document control, and internal audits. Familiarity with NATA and ISO15189 standards is essential, along with the ability to collaborate effectively across teams and with external bodies.
You bring a structured, proactive approach to quality assurance and thrive in dynamic, fast-paced environments. Attention to detail, adaptability, and a commitment to continuous improvement are key to success in this role.
Experience in accredited clinical laboratories is highly valued. Exposure to molecular diagnostics, next-generation sequencing (NGS), or precision medicine will be an advantage.
If you value accuracy, accountability, and collaboration — and are ready to contribute to a team driving innovation in cancer genomics — we'd love to hear from you.
Job responsibilities
The job holder will be required to carry out the following responsibilities, activities and duties:
- To liaise with external accreditation bodies (NATA, CAP) to ensure external assessments/inspections are planned and managed and oversee the effective completion of corrective action as required by the findings and reports of the inspectors
- To manage, maintain and develop an effective laboratory Quality Management System (QMS) and supporting documentation in compliance with current clinical laboratory standards.
- To ensure laboratory Policies and Procedures reflect current practice and are reviewed as stated within the policies of the QMS.
- To operate an effective system for document control.
- To investigate result and service complaints and incidents and ensure that effective immediate and follow up actions are taken and fully documented.
- To plan, initiate and supervise a program of internal audits against defined quality performance measures, ensuring that effective immediate and follow up actions are taken.
- To liaise with users on matters of laboratory quality
- To plan and organise regular and effective departmental Quality Meetings and the Annual Management Review.
- To provide reports and collate information regularly for Quality, departmental meetings and the Annual Management Review.
- To ensure staff compliance with relevant standards.
- To ensure all relevant documentation within the QMS is fully document controlled.
- To ensure and co-ordinate the review, of relevant Standard Operating Procedures (SOPs), policies and procedures
The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary.
Experience
Essential
- Sound computer skills
- Experience with electronic quality management systems
- Understanding of quality assurance procedures
- Able to communicate well with peers and senior staff and provide judgement on a range of complex problems
- Able to support a pragmatic quality culture
- Used to working in a busy environment
- Adaptability, flexibility and ability to cope with uncertainty and change
Desirable
- Experience of working in NATA/NPAAC ISO15189 accredited laboratories
- Experience with CAP guidelines
- Knowledge of NGS testing, molecular pathology, and precision medicine
