Director of Quality Excellence

2 weeks ago

Brisbane, Queensland, Australia KE Select Full time

About KE Select, a leading Life Science & Medical Technology recruitment firm. Our team is dedicated to connecting talented professionals with exciting opportunities in the industry.

**Job Overview**

We are seeking a highly skilled Director of Quality Excellence to join our dynamic team. This role will involve leading and managing all quality assurance activities, ensuring compliance with regulatory requirements, and driving a culture of continuous improvement.

**About the Role**

The ideal candidate will have a strong background in biologics manufacturing, with experience in quality assurance roles within the pharmaceutical industry. They will be responsible for developing and implementing comprehensive quality systems, including document control, deviation management, and CAPA processes.

  • **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.

**About You**

To be successful in this role, you will need:

  • A Bachelor's degree or higher in a relevant scientific or engineering discipline.
  • A minimum of 7 years of experience in quality assurance roles within the biologics or pharmaceutical industry.
  • Demonstrated leadership experience, with the ability to inspire and develop a high-performing team.
  • Familiarity with biologics manufacturing processes, including RNA-based therapeutics.
  • 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.
  • The ability to manage multiple projects simultaneously and prioritise workload effectively in a dynamic environment.

**What We Offer**

We offer a competitive salary package, including a base salary of $120,000 - $150,000 per annum, depending on experience.

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