Quality Systems Specialist

On Q Recruitment is proud to exclusively partner with Viral Vector Manufacturing Facility (VVMF) to build their quality function. As VVMF establishes a world-class facility to deliver advanced viral vector manufacturing solutions for the biopharmaceutical industry, they are seeking a Quality Systems Specialist to join their growing team.

About the Role:

Reporting to the Quality Systems Manager, the Quality Systems Specialist will be responsible for supporting, maintaining, and continuously improving VVMF Quality System in accordance with applicable regulations and industry best practices. This role is critical in ensuring product quality, GMP compliance, and driving continuous improvement initiatives across the organisation.

Key Responsibilities:

• Work closely with the Quality Systems Manager to achieve quality goals and objectives.
• Support the development and operation of the Quality System, ensuring process ownership for key areas such as document control, change management, deviations, CAPA, audits, risk assessments, and supplier qualification.
• Identify and drive quality system improvement projects using process improvement and problem-solving methodologies.
• Ensure compliance with regulatory requirements (TGA, FDA, EMA) by maintaining robust GMP and data integrity practices.
• Support internal audits and regulatory inspections, assisting in inspection readiness and compliance activities.
• Monitor quality system performance through tracking, trending, and reporting key metrics.
• Participate in management review meetings, ensuring leadership is informed of quality system trends and potential areas for improvement.
• Provide training and mentoring to internal teams, fostering a culture of quality and compliance.
• Serve as a key contact for internal and external stakeholders regarding quality system-related matters, ensuring effective communication and collaboration.

Qualifications and Skills:

• A degree in Life Sciences, Biotechnology, or a related field.
• At least 5 years of experience in quality systems within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Strong understanding of quality management principles, including deviation management, CAPA, and change control.
• Experience with electronic quality management systems (eQMS).
• Knowledge of TGA, FDA, and EMA regulatory requirements for pharmaceutical manufacturing.
• Excellent problem-solving, analytical, and communication skills with the ability to engage cross-functional teams.

This is a unique opportunity to join a pioneering organisation and contribute to the development of a state-of-the-art viral vector manufacturing facility.

For a confidential conversation , please email Grace Bitodi at gbitodi@onqrecruitment.com.au .