Senior Quality Assurance Manager

2 days ago

Brisbane, Queensland, Australia KE Select Full time
About the Role

The ideal candidate will possess a deep understanding of biologics manufacturing processes, including RNA-based therapeutics, and have experience in quality assurance roles within the industry. They will be able to lead and manage all QA activities, ensuring compliance with FDA, EMA, and other regulatory requirements governing biologics manufacturing and quality systems.

Key Responsibilities
  • Leadership: Provide strategic leadership and direction for the quality assurance function, aligning with organisational goals and objectives.
  • Regulatory Compliance: Oversee compliance with FDA, EMA, and other regulatory requirements governing biologics manufacturing and quality systems.
  • Quality Systems Management: Develop, implement, and maintain comprehensive quality systems, including document control, deviation management, and CAPA processes.
  • Quality Assurance Operations: Manage all aspects of quality assurance operations, including batch release, product disposition, and oversight of manufacturing and testing activities.
  • Risk Management: Implement risk-based approaches to quality management and develop strategies to mitigate risks associated with biologics manufacturing processes.
  • Audits and Inspections: Coordinate regulatory inspections, customer audits, and internal audits, ensuring preparedness and timely response to audit findings.
  • Continuous Improvement: Drive a culture of continuous improvement by identifying opportunities for process optimisation and quality enhancements.
  • Training and Development: Provide guidance and training to staff on quality systems, regulatory requirements, and best practices in quality assurance.
  • Supplier Quality Management: Oversee supplier quality management activities, including qualification, audits, and performance monitoring.
  • Quality Metrics and Reporting: Establish KPIs and metrics to monitor the effectiveness of quality systems and provide regular reports to senior management

Requirements:

  • Bachelor's degree or higher in a relevant scientific or engineering discipline.
  • Minimum of 7 years of experience in quality assurance roles within the biologics or pharmaceutical industry, with a strong understanding of GMP and regulatory requirements.
  • Demonstrated leadership experience, with the ability to inspire and develop a high-performing team.
  • Familiarity with biologics manufacturing processes, including RNA-based therapeutics, is necessary.
  • Excellent communication skills and the ability to collaborate effectively across interdisciplinary teams.
  • Strong analytical and problem-solving skills, with a focus on data-driven decision-making.
  • Ability to manage multiple projects simultaneously and prioritise workload effectively in a dynamic environment.

We offer a competitive salary of $120,000 - $150,000 per annum, commensurate with experience, plus benefits and opportunities for professional growth.

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