Cell and Gene Therapy Quality Specialist

2 weeks ago

City Of Parramatta Council, Australia Southern NSW Local Health District Full time

**About Us**

Southern NSW Local Health District is responsible for providing healthcare services to the people of southern New South Wales. We are committed to our vision of delivering high-quality, patient-centered care that meets the needs of our community.

About the Role

We are seeking a highly skilled Cell and Gene Therapy Quality Specialist to join our team at Westmead Hospital. As a key member of our quality management team, you will play a critical role in ensuring the highest standards of quality and compliance in cell and gene therapy product manufacture and clinical trials.

Key Responsibilities

  • Support operational and quality management activities related to cell and gene therapy product manufacture and clinical trials
  • Contribute to the development and implementation of quality assurance strategies and procedures
  • Collaborate with multidisciplinary teams to ensure compliance with regulatory requirements and industry standards
  • Provide expert advice and guidance on quality management and quality control practices

What You'll Need

  • Bachelor of Science Degree in the physical or biological sciences or extensive equivalent experience
  • Demonstrated experience in clinical research or clinical service provision, in biological or pharmaceutical development and experience in quality assurance
  • Understanding of regulatory requirements for cell and gene therapies
  • Excellent organisational, record keeping, and project management skills
  • Advanced computer system skills and experience with electronic quality management software such as Q-Pulse (Ideagen)
  • Proven excellent oral, written, and interpersonal communication skills within a multidisciplinary environment
  • Demonstrated ability to work effectively both independently and within a team environment

Remuneration and Benefits

The successful candidate will receive an annual salary range of $84,436 - $112,331, commensurate with experience. In addition to a competitive salary, we offer a range of benefits including access to professional development opportunities, flexible working arrangements, and a comprehensive employee assistance program.

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