Quality Manager

i‑Pharm Consulting; Dubbo; On-site; AUD 110,000 - 160,000; Full time

Job summary

i‑Pharm Consulting in Dubbo is seeking a Quality Manager to ensure regulatory compliance and maintain ISO certifications across the organisation. You will drive continuous improvement of the QMS and lead audit programs to support quality across products and processes.

The role requires leadership to align with ALCOA+ principles, manage risk assessments, and collaborate with regulators, customers, and suppliers to sustain high quality standards.

Qualifications

• Experience leading QMS in regulated industries.
• Strong knowledge of ISO 9001, ISO 13485, GMP, and AU regulations.
• Experience with ISO 14971 or ISO 31000 risk management.
• Proven ability to lead audits and drive CAPA.

Responsibilities

• Monitor QMS performance via data analyses and drive improvements.
• Ensure QMS is established, implemented, maintained and improved.
• Document processes per ALCOA+ principles.
• Promote regulatory and QMS awareness across the organisation.
• Lead internal and external audits, ISO surveillance and recertification.
• Lead risk assessments and mitigate product quality risks (ALARP).
• Oversee supplier qualification and quality control for materials and services.

Skills

QMS management

Regulatory compliance

Auditing

CAPA

Stakeholder comms

Lean Six Sigma

Education

Bachelor's degree in science/engineering

Lead Auditor ISO 9001/13485

Job description

About the Company

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 strong 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 9001 or ISO 13485, 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 9001, ISO 13485, GMP, and Australian regulatory requirements
• In-depth understanding of ISO 14971 or ISO 31000 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