Quality Assurance Systems Leader

1 week ago

Melbourne, Victoria, Australia beBeeAssurance Full time $160,000 - $220,000

Quality Assurance Systems Leader

Job Description:

As a Quality Assurance Systems Leader, you will develop and implement Quality Assurance systems to ensure compliance with company standards and regulatory guidelines. This includes maintaining quality systems, defining procedures for quality processes, and managing systems for timely product release.

Key Responsibilities:

  • Develop and implement Quality Assurance systems
  • Maintain quality systems including standard operating procedures (SOPs)
  • Define procedures governing quality processes: document management, change control, deviation handling, product quality review, training, supplier qualification, and audit management
  • Manage quality systems for timely product release
  • Ensure preparation, successful conduct, and follow-up of all regulatory inspections, self-inspections, and customer audits
  • Cross-functionally collaborate to facilitate quality assurance training and communicate best practices

Qualifications:

  • Relevant scientific discipline degree; advanced degree preferred
  • 8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry; 3+ years' leadership/team management experience
  • Experience with regulatory authorities and international inspections
  • Demonstrated success in project management and business/QA systems
  • Experience within a global matrix organization
  • Knowledge of appropriate regulatory requirements including GMP/GQP

Benefits:

This role offers the opportunity to work in a dynamic environment, collaborate with cross-functional teams, and contribute to the development of quality systems that ensure compliance and excellence.

Other Information:

This position requires a strong understanding of quality systems, regulatory requirements, and leadership skills. The ideal candidate will be able to develop and implement quality systems, manage quality processes, and collaborate with cross-functional teams.

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