Quality Manager
In line with our expanding R&D, operational, and clinical trial footprint, Novoviah is establishing a Quality Management System covering medical devices, IVD's, pharmaceuticals, food, GMP, and laboratories.
We are seeking a permanent, full-time Quality Manager who is eager to build and take ownership of a broad QMS from scratch in a small, growing, and mission-driven organisation.
This is a hands-on, high-impact role suited to someone who is meticulous yet pragmatic, and who understands that quality systems must be robust, but also usable, scalable, and tailored to a fast-moving biotech environment.
The Quality Manager will partner closely with the Director of Operations and collaborate across R&D, Clinical, Operations, and Commercial functions to embed quality deep into the company's DNA.
Key responsibilities
Quality Management System (QMS) Development & Oversight
Design, implement, and maintain Novoviah's end-to-end QMS in alignment with ISO ********** CFR 820 principles.
Develop and manage SOPs, work instructions, templates, and controlled document systems.
Build practical processes for change control, risk management, deviation handling, and CAPA management.
Ensure the QMS is fit-for-purpose for a small, nimble team while scalable for future TGA and FDA submissions.
Operational Quality & Compliance
Oversee quality standards for product assembly, packaging, and release.
Support validation, verification, and testing activities across product development and operations.
Lead supplier qualification and ongoing supplier performance monitoring.
Prepare for and coordinate internal and external audits and regulatory inspections.
Maintain quality records, logs, and controlled documentation.
Training & Culture
Deliver onboarding and ongoing quality training across the organisation.
Coach teams to adopt quality practices that are thorough yet efficient.
Help embed a quality-first mindset across a rapidly growing team.
Regulatory Preparation & Certification
Prepare documentation for TGA, FDA, and ISO-related pathways.
Contribute to technical files, risk assessments, validation packages, and product dossiers.
Support quality compliance for investigational products used in clinical research.
Identify quality risks and improvement opportunities across end-to-end operations.
Conduct root cause analysis and implement corrective and preventive actions.
Introduce tools and processes that enhance efficiency and quality performance.
Skills & experience
5-7+ years' experience in quality roles within biotech, medtech, diagnostics, pharma, or a regulated scientific environment.
Strong knowledge of QMS principles (e.g. ISO *****, 21 CFR 820, ICH-Q10).
Strong knowledge of GMP principles.
Knowledge of food safety principles and HACCP.
Experience drafting SOPs and implementing quality systems or controlled document frameworks.
Excellent attention to detail, organisation, and follow-through.
Confidence working across small, multidisciplinary teams.
Strong communication and training skills.
Experience establishing or scaling a QMS in a smaller or emerging organisation.
Familiarity with TGA and/or FDA regulatory requirements.
Experience with risk management (ISO *****) and supplier quality.
Exposure to clinical research, diagnostic products, or immunology-related fields.
Energy, adaptability, and enthusiasm for building systems from the ground up.
Mount Warren Park, Queensland, Australia
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