Cell Therapy Quality Expert

2 days ago

Brisbane, Queensland, Australia beBeeQuality Full time $142,044 - $149,235
Job Overview

This is a key leadership position focused on ensuring the highest standards of quality in cell therapy manufacturing. We are seeking an experienced Quality Manager to join our team and lead the development and implementation of our quality management system.



Responsibilities
  • Lead the development, implementation, and maintenance of our quality management system to ensure ongoing compliance with GMP regulations.
  • Oversee QA and QC functions including document control, CAPAs, audits, supplier management, and trend analysis.
  • Ensure product safety, effectiveness, and timely release through oversight of batch record reviews.
  • Maintain up-to-date knowledge of Australian and international GMP standards.
  • Collaborate with internal stakeholders to build and develop a high-performing quality team with a focus on collaboration and continuous improvement.


Requirements
  • Extensive experience in GMP quality systems in a cell therapy, medical laboratory, or similar setting.
  • Deep understanding of GMP principles, the Therapeutic Goods Act, and relevant codes.
  • Proven leadership and people management skills with strong emotional intelligence.
  • Strong organisational and communication abilities with a track record of managing complex projects.
  • Degree in life sciences; postgraduate qualifications and knowledge of FDA/EMA regulations are desirable.


Benefits
  • Salary range is $142,044 to $149,235 plus super and generous salary packaging.
  • State of the art facilities
  • Stimulating work setting focused on cutting edge medical research
  • Supportive and collaborative team environment
  • Parental Leave provisions

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