Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. The company is now working on a major new initiative to launch its flagship ViraxImmune™ immune profiling platform. This technology is expected to facilitate the diagnosis of chronic conditions such as post viral syndromes, Lyme disease, chronic inflammation and ME/CFS.
In parallel Virax Biolabs is rolling out ImmuneSelect, a range of products dedicated to immunology and clinical research.
We are seeking an experienced Quality Assurance Manager to lead our company's efforts in obtaining dual ISO 13485 and ISO 9001 certifications. In this role, you will be responsible for creating and managing all necessary documentation and processes, leading the submission process, and coordinating all activities required to achieve these certifications.
Once certifications are obtained, you will focus on internal quality assurance to ensure all documentation and processes remain up to date and compliant. This is a fantastic opportunity for someone looking to have full ownership of quality assurance and processes within a small, fast-growing biotechnology business, making a significant impact on healthcare for chronic patients.
Key Responsibilities:
- Lead the development and implementation of the Quality Management System (QMS) for ISO 13485 and ISO 9001 certifications.
- Create and manage technical files, Standard Operating Procedures (SOPs), risk management reports, and other required documentation.
- Collaborate closely with product development and manufacturing teams to ensure alignment with quality standards.
- Serve as the main point of contact for external auditors and certification bodies.
- Perform internal audits and drive continuous process improvements.
- Train and educate internal teams on quality management processes.
What your background should like:
- Minimum of 5 years of experience in the in-vitro diagnostics or medical devices industry.
- Proven experience in technical writing and documentation management.
- Prior experience working in a small company is highly beneficial.
- Ability to work independently in a fast-paced environment with excellent project management and problem-solving skills.
- Strong communication skills with the ability to collaborate across teams.
What Virax Biolabs Offers
- Competitive salary package
- Performance-based bonus plans
- Employee stock options program
- 28 days of annual leave + Bank holidays
