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Chief Quality Officer

2 months ago

Sydney, New South Wales, Australia On Q Recruitment Full time
Are you a seasoned Quality professional ready to drive excellence in biotech manufacturing?

Our client, a pioneering force in viral vector manufacturing, is seeking a visionary Chief Quality Officer to spearhead their Quality function. This is a rare opportunity to shape the future of quality management in a cutting-edge industry.

About the Role:
As the Chief Quality Officer, you will report directly to the Chief Executive Officer and play a pivotal role in establishing and leading the Quality function. You will be instrumental in setting the strategic direction, building and leading a high-performing Quality team, and ensuring the facility meets all regulatory requirements.

This role is critical as the organisation transitions from a pilot-stage operation to a global, cGMP-licensed commercial-scale facility. You will guide this transformation, provide strategic vision, and ensure that quality standards are upheld as the organisation scales its operations and expands into international markets.

Your Key Responsibilities Will Include:
  • Enterprise-Wide Quality Leadership: Develop and implement the Site Quality Plan and Quality function objectives. Ensure compliance with cGLP/cGMP and all relevant regulatory standards.
  • Team Leadership: Build and lead a team of Quality professionals. Foster a collaborative and innovative work environment, ensuring your team remains engaged and motivated.
  • Customer-Centric Focus: Act as the primary contact for regulatory agencies and customers on quality and compliance issues. Manage customer audits and ensure successful outcomes.


To Be Considered for This Role, You Will Have:

  • A bachelor's degree in a related science or business discipline.
  • A minimum of 10 years of industry experience in a quality-regulated biotech, cell and gene therapy or pharmaceutical manufacturing environment.
  • At least 5 years of managerial experience with a proven track record of leadership and problem-solving.
  • Extensive knowledge of TGA, OGTR, and international regulatory requirements (GxP).
  • Strong organizational, interpersonal, communication, and presentation skills.

This role offers a unique opportunity to be at the forefront of a rapidly evolving industry, working with a team dedicated to pioneering solutions in viral vector manufacturing. If you are passionate about quality excellence and are ready to take on a challenge that will define your career, this is the role for you.

For a confidential conversation about this role, please contact Grace Bitodi, Recruitment Manager, at On Q Recruitment.