A specialist provider of animal-derived biological materials to the global healthcare and life sciences industries.
Headquartered in Dubbo, NSW, with operations across Australia and New Zealand, the company supplies materials used in medical devices, pharmaceuticals, vaccines, diagnostics and research.
Working closely with international customers, the business develops tailored processing and supply chain solutions, with a solid focus on quality, traceability and meeting customer and regulatory requirements.
About the Role
The Quality Manager is responsible for ensuring that the organisation's products, services, and internal processes meet all regulatory requirements, quality standards, and customer expectations.
This role drives continuous improvement in quality assurance and compliance across the organisation, maintaining ISO certifications, and fostering a culture of quality excellence.
The Quality Manager provides strategic leadership in quality management, ensuring that the organisation operates efficiently and in compliance with industry regulations and best practices.
Responsibilities
Monitor the performance and effectiveness of the QMS through the analyses of data and recommending needs for improvement
Ensure that the Quality Management System (QMS) is established, implemented, maintained, and continually improved
Ensure processes needed for QMS are documented, following ALCOA+ principles
Promote awareness of applicable regulatory and QMS requirements throughout the organisation
Align, incorporate and execute Quality Management Plans, and act as the control for these plans




Act as the liaison between the organisation and regulatory bodies, auditors, customers and stakeholders for quality and customer regulatory activities
Lead internal and external audits, including ISO surveillance and recertification, supplier, and customer inspections
Lead cross-functional risk assessments and ensure product quality risks are mitigated (ALARP)
Assess the viability and effectiveness of corrective and preventive actions, and assign actions based on risk priority
Oversee supplier qualification and ongoing quality control for raw materials and outsourced services
Qualifications
Bachelor's degree in science, Engineering, or a related field
Certified Lead Auditor for ISO **** or ISO *****, Lean Manufacturing or Lean Six Sigma certification, or equivalent industry qualifications
Required Skills
Proven experience managing QMS in a regulated industry, with medical device and food manufacturing experience
In-depth understanding of ISO ****, ISO *****, GMP, and Australian regulatory requirements
In-depth understanding of ISO ***** or ISO ***** and applying best practice
Demonstrated ability to manage internal and external audits, ensuring adherence to industry best practices
Experience in leading root cause analysis using structured methodologies and effective CAPA implementation
Strong people management skills with experience in mentoring, coaching, and developing high-performing teams
Ability to effectively communicate with internal and external stakeholders
Experience in Lean Manufacturing or Lean Six Sigma, or other quality improvement methodologies
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📌 Quality Manager (Dubbo)
🏢 i-Pharm Consulting
📍 Dubbo