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Head of Quality Control (GMP Cell Therapy)

QIMR Berghofer · Brisbane

New
Senior 🇬🇧 English
validation assay qualification environmental monitoring stability testing quality management systems

Job description

About the role

The Head of Quality Control will lead QC operations within Q‑Gen Cell Therapeutics, a GMP facility that manufactures investigational cell therapy products. Reporting to senior management, you will ensure safe, effective, and compliant production while driving continuous improvement and operational excellence.

Key responsibilities

  • Lead and manage the Quality Control team to deliver efficient, high‑quality testing services in a GMP environment.
  • Ensure all QC testing complies with GMP standards, regulatory requirements and internal quality systems.
  • Oversee laboratory activities including environmental monitoring, microbiological, immunological, chemical and stability testing.
  • Implement and qualify new QC equipment and processes.
  • Manage, review and improve QC documentation.
  • Conduct data trending, quality event investigations and out‑of‑specification analyses.

Required profile

  • Extensive experience in Quality Control within a regulated environment such as cell therapy, pharmaceutical manufacturing, pathology or clinical research.
  • Proven leadership ability to build and develop high‑performing teams.
  • Strong knowledge of GMP principles and regulatory requirements for human cell therapy.
  • Experience in validation, assay qualification and continuous improvement initiatives.
  • Excellent organisational and communication skills with the ability to manage competing priorities.
  • Relevant postgraduate qualification in life sciences, immunology, biochemistry or equivalent experience.

Required skills

  • GMP compliance
  • Validation and qualification of assays
  • Environmental monitoring
  • Microbiological testing
  • Immunological testing
  • Chemical testing
  • Stability testing
  • Quality management systems

What we offer

  • Salary range $127,894 – $137,907 plus super and generous salary packaging.
  • Full‑time, fixed‑term 2‑year appointment.
  • Opportunity to work in a world‑leading translational medical research institute.

Questions fréquentes

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Published 3 days ago

Expires 1 month from now

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QIMR Berghofer

Brisbane