Quality Manager - QMS, Systems Compliance & Continuous Improvement

** Lead the evolution of Quality Systems, influence organisational excellence, and shape the future of quality in an innovative biotechnology environment. **

At Vaxxas, our goal is to create a healthier world by transforming how the world receives life-saving vaccinations.  

We’re developing a next-generation delivery platform, the high-density microarray patch (HD-MAP), that pushes beyond traditional approaches to target immune cells in the skin; creating a faster, more effective, and more accessible vaccination solution. 

Simple to use and less reliant on cold-chain for distribution, the HD-MAP is designed to make reaching those who need it most, easier. 

Our team brings together scientists, engineers, regulatory and quality professionals who are passionate about improving global health outcomes through their cutting-edge research, innovative platform development, and advanced manufacturing approaches.  

About the Role 

Reporting to the Senior Vice President, Quality, this leadership role is responsible for overseeing the Quality Systems team and driving the ongoing effectiveness, compliance, and evolution of Vaxxas' Quality Management System (QMS).

This is a unique opportunity for an experienced Quality professional to influence quality culture, lead digital quality initiatives, partner across the business, and shape the systems and processes that support the development and manufacture of innovative healthcare technologies.

You will play a pivotal role in ensuring our quality systems remain scalable, compliant, and fit for purpose as the organisation continues to grow.

Key Responsibilities

Leadership & Quality Systems

• Lead, mentor, and develop the Quality Systems team, creating a high-performing and collaborative team environment.
• Drive the ongoing management, effectiveness, and continuous improvement of the Vaxxas Quality Management System (QMS).
• Establish team goals, priorities and performance expectations aligned to departmental and company objectives.
• Manage team workflows and resources to ensure efficient delivery of Quality Systems activities.

Continuous Improvement & eQMS

• Lead initiatives to improve and optimise quality systems, processes, and ways of working across the business.
• Champion the implementation, adoption and ongoing enhancement of electronic Quality Management Systems (eQMS) and other business systems that support quality processes.
• Embed quality risk management principles and continuous improvement practices throughout the organisation.

Compliance & Business Partnership

• Ensure compliance with GMP, applicable regulations, company procedures, and quality standards.
• Oversee key quality processes including document control, change management, training, and quality metrics.
• Partner closely with Manufacturing, Technical Operations, Product Development, and senior stakeholders to solve complex quality challenges and support business growth.
• Support Management Review activities and monitor Quality Management System performance to identify opportunities for continual improvement.
• Act as a key participant in internal audits, supplier audits, and external inspections.

Quality Culture & Influence

• Champion a quality-first mindset across the organisation.
• Build engagement and understanding of quality requirements through effective stakeholder management, communication, and influence.
• Drive cultural change initiatives that strengthen quality ownership and accountability across the business.

About You

You are an experienced Quality leader who combines strong technical knowledge with the ability to influence, engage and drive change within a regulated environment.

You will bring:

• A degree in Science, Engineering, Pharmacy, or a related discipline.
• Demonstrated leadership experience within pharmaceutical, biotechnology and/or medical device organisations.
• Proven success managing and improving Quality Management Systems in highly regulated environments.
• Experience leading quality system improvement, business process improvement and/or eQMS implementation initiatives.
• Strong understanding of quality risk management, change management and continuous improvement principles.
• Experience working collaboratively with cross-functional stakeholders, including senior leadership teams.
• Strong communication, stakeholder engagement, and people leadership skills.
• The ability to manage multiple priorities and thrive in a fast-paced, evolving environment.

Highly Regarded

• Experience within organisations performing aseptic manufacturing.
• Knowledge of GLP, GMP and/or ISO 13485 requirements.
• Experience working within regulatory frameworks such as TGA, FDA, MHRA and/or EMA.
• Experience with validation of manufacturing processes, equipment, facilities, test methods, or computerised systems.
• Knowledge of GMP requirements associated with products intended for clinical studies.

Why Join Vaxxas?

At Vaxxas, you'll join a pioneering biotechnology company developing innovative healthcare technologies with global impact.

This role offers the opportunity to:

• Lead and shape a critical Quality function.
• Drive the ongoing evolution of Quality Systems and digital quality initiatives.
• Influence quality culture across a growing organisation.
• Work alongside talented, collaborative teams committed to innovation and excellence.
• Make a meaningful contribution to the future of healthcare technology.

Learn more at www.vaxxas.com

If you're a quality leader who enjoys building capability, improving systems, and driving meaningful change in a regulated environment, we'd love to hear from you.

To be considered, please submit your Resume, together with a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the 'apply for this job' function.