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Quality Assurance Manager

Toll Group · Sydney

New
Senior 🇬🇧 English
TGA regulations PIC/S Code of GMP ISO 9001 ISO 13485 auditing

Job description

About the role

Toll Healthcare is seeking an experienced Quality Assurance Manager to lead and continuously enhance our quality systems, ensuring compliance with regulatory, customer, and industry requirements across healthcare logistics operations.

Key responsibilities

  • Lead and maintain the vendor assurance program, including supplier qualification, audits, and Quality Agreements.
  • Oversee change controls, customer complaints, CAPA, and non‑conformance processes to ensure timely resolution.
  • Review and approve quality documentation, investigations, and quality events.
  • Drive continuous improvement initiatives, root‑cause investigations, and corrective actions.
  • Support onboarding of new customers and sites from a quality and compliance perspective.

Required profile

  • Science degree or equivalent qualification.
  • 10 years' quality experience within pharmaceutical, medical device, diagnostics, or consumer health industries.
  • Strong knowledge of TGA regulations and PIC/S Code of GMP.
  • Working knowledge of ISO 9001 and ISO 13485 standards.
  • Auditing experience.

Required skills

  • Quality Management Systems (QMS) expertise.
  • CAPA, non‑conformance, change control, complaint handling.
  • Supplier quality program management.
  • Analytical and root‑cause investigation skills.
  • Project management of multiple initiatives.

Questions fréquentes

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Published 14 hours ago

Expires 1 month from now

9 views · 0 interested

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Toll Group

Sydney