Quality Assurance Leadership Position

3 days ago

Melbourne, Victoria, Australia beBeeQuality Full time $180,000 - $240,000

**Quality Assurance Expert Role Summary**

The Site Quality Lead will oversee quality assurance processes at the Australia manufacturing site, ensuring compliance with regulatory requirements and supporting the delivery of high-quality mRNA product. This leadership role involves driving a strong quality culture, delivering on production commitments, and closely monitoring performance.

Main Responsibilities:

  • Establish and lead an organization responsible for internal Drug Substance and Drug Product manufacturing operations, technology transfers, and CQV.
  • Ensure site operations align with regulatory and GMP expectations to sustainably deliver high-quality product.
  • Develop and implement quality policies, procedures, and training programs for the site.
  • Review and approve cGMP documentation, ensuring alignment with global processes and platforms.
  • Ensure Quality Assurance presence on the manufacturing floor and robust execution of Batch Disposition.
  • Analyze and present key quality performance indicators to identify and address quality system or product issues.
  • Establish and maintain a robust Quality Control laboratory able to meet business commitments.
  • Interface with regulatory authorities and ensure inspection readiness, providing guidance and support relative to Good Manufacturing Practices (GMPs).

Requirements:

  • Bachelor's or Master's degree in Sciences, Engineering, or equivalent combination of education and experience.
  • 15+ years of pharmaceutical work experience with emphasis on current Good Manufacturing Practices.
  • Excellent leadership skills with ability to operate independently, collaborate cross-functionally, and foster a positive culture.

What We Offer:

  • Personalized benefit programs and well-being resources.
  • Quality healthcare and insurance benefits.
  • Lifestyle Spending Accounts for well-being.
  • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and discretionary year-end shutdown.
  • Educational resources and savings plans.

About Us:

We strive to build the leading mRNA technology platform, infrastructure to reimagine medicine creation and delivery, and a world-class team. We believe in giving our people opportunities to grow and thrive.

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