Quality Manager - Regulatory & QMS Leader

i‑Pharm Consulting; Dubbo; On-site; AUD 120,000 - 180,000; Full time

Job summary

i‑Pharm Consulting in Dubbo, NSW, is seeking a Quality Manager to ensure products, services, and processes meet regulatory standards and customer expectations. You will lead the quality management system, drive continuous improvement, and sustain ISO certifications across the organisation.

The role requires strong audit experience, risk management, and people leadership to mentor teams and coordinate with regulators, customers, and suppliers in a fast-moving life sciences environment.

Qualifications

• Proven experience managing QMS in regulated industries (medical devices and food manufacturing).
• Deep knowledge of ISO 9001, ISO 13485, GMP and Australian regulatory requirements.
• Experience with ISO 14971 or ISO 31000 risk management.
• Strong audits experience, including internal and supplier/customer audits.
• Lean Manufacturing or Lean Six Sigma, or similar improvement methodologies.
• Bachelor's degree in science, engineering, or related field.
• Certified Lead Auditor for ISO 9001 or ISO 13485 or Lean Six Sigma.

Responsibilities

• Monitor QMS performance through data analysis and continuous improvement.
• Establish, implement, maintain, and improve the QMS.
• Lead internal and external audits including ISO surveillance.
• Coordinate CAPA actions and root-cause analysis.
• Liaise with regulators, auditors, customers and stakeholders.
• Oversee supplier quality and raw material controls.
• Promote ALCOA+ data integrity and regulatory compliance.

Skills

QMS management

Auditing

CAPA

Lean Six Sigma

Regulatory knowledge

Leadership

Stakeholder comms

Education

Bachelor's degree in science/engineering/related

Lead Auditor certification (ISO 9001/13485)

Tools

ALCOA+

GMP

ISO 9001/13485 standards

Job description

i‑Pharm Consulting in Dubbo, NSW, is seeking a Quality Manager to ensure products, services, and processes meet regulatory standards and customer expectations. You will lead the quality management system, drive continuous improvement, and sustain ISO certifications across the organisation.

The role requires strong audit experience, risk management, and people leadership to mentor teams and coordinate with regulators, customers, and suppliers in a fast-moving life sciences environment.