About This Role
Leading the Quality function and ensuring the Quality Management System remains effective, inspection-ready, and aligned with regulatory requirements is the core of this leadership role. It supports product quality, operational excellence, and continuous improvement across the organization. You will lead and develop the Quality Assurance and Quality Control teams, working closely with cross-functional stakeholders to embed a strong quality culture and ensure products, processes, and systems consistently meet the highest standards.
Responsibilities
- Lead and develop the Quality Assurance and Quality Control teams, building a high-performing and engaged department with clear goals, objectives, and accountabilities
- Ensure the Quality Plan is delivered on time and to the required standards
- Provide Quality Operations oversight across the organisation
- Act as a core team member for applicable projects, providing Quality input and decision-making support
- Promote a culture of continuous improvement within the Quality organisation by identifying improvement opportunities and championing effective initiatives
- Ensure the Quality Management System, including the eQMS, is established, implemented, maintained, and continually improved in line with applicable regulatory standards
- Manage and mentor the Quality Team members so they provide consistent specialist guidance on quality requirements and compliance expectations
- Maintain accurate QMS process documentation and ensure it supports compliance, operational effectiveness, and continuous improvement
- Oversee day-to-day execution of the QMS to support effective compliance and operational control
- Maintain and promote awareness of applicable regulatory and QMS requirements throughout the organisation
- Report on QMS performance, including Quality Objective KPIs, audit outcomes, compliance with legal and other requirements, and regular monitoring of process performance
- Consider interdependencies between Quality Assurance, IT, Regulatory, Clinical, Manufacturing, Supply Chain, and other relevant functions when developing or improving quality system processes
- Ensure released product meets release criteria and act promptly to isolate, correct and implement corrective actions where product/process nonconformance is detected
- Ensure documentation and processes follow ALCOA principles and Good Manufacturing Practice expectations
- Ensure equipment, software, environment, people, products, and processes remain compliant with the QMS, with timely corrective action where required
- Authorise release only for product that meets specified quality criteria for sale or evaluation
- Support regulatory inspections and external audits by providing expert input, presenting QMS information clearly, coordinating responses, and supporting timely resolution of requests
