Quality Systems Manager

Proclinical is seeking a Quality Systems Manager to join our client, a pioneering biologics manufacturer establishing one of Australia’s first commercial facilities dedicated to viral vector production for advanced therapies.

Uniquely embedded within a major health, education, research, and innovation precinct, our client is positioning itself as a leading CDMO in the Asia–Pacific region.

As the organisation scales toward full commercial operations and prepares for further facility expansion, this role will be central to strengthening the site Quality Management System and supporting ongoing TGA GMP inspection readiness.

Why this role?

This is a rare opportunity to lead Quality Systems within one of Australia’s first commercial viral vector manufacturing facilities.

You’ll help mature the quality framework supporting clinical and commercial advanced therapies manufacturing, while partnering closely with senior leaders across Manufacturing, QC, Engineering, Supply Chain and Operations.

Role Overview

Reporting to the Chief Quality Officer, the Quality Systems Manager will oversee the effectiveness, compliance, and continuous improvement of the site QMS.

You’ll manage core quality systems including document control, change control, deviations, CAPA, complaints, recall, quality agreements, audits, supplier qualification, risk assessments, inspection readiness, data integrity and quality performance reporting.

This role will suit someone who can combine strong GMP knowledge with practical, solutions-focused leadership in a growing CDMO environment.

Key Responsibilities

• Manage and continuously improve the site Quality Management System.
• Oversee key QMS processes including documentation, change control, deviations, CAPA, complaints, recall, audits, supplier qualification and risk management.
• Lead internal audit schedules and support customer, third-party and regulatory audits.
• Drive inspection readiness activities and support responses to audit observations.
• Lead and mature the site data integrity program.
• Track, trend and report on quality system performance, including management review.
• Establish governance forums to monitor quality records, timelines and system effectiveness.
• Identify and lead quality system improvement initiatives.
• Provide quality systems advice to Manufacturing, QC, Engineering, Logistics, Supply Chain and other operational teams.
• Foster a proactive quality culture through coaching, training and cross-functional engagement.
• Support the growth of the Quality Systems function as the organisation scales.

Skills & Experience

• Bachelor’s degree in Science, Engineering, Pharmaceutical Science, Biotechnology or a related technical discipline.
• Demonstrated experience in Quality Systems management within a GMP-regulated environment.
• Strong knowledge of cGMP, TGA, PIC/S and relevant international regulatory expectations.
• Experience with QMS processes such as document control, change control, deviations, CAPA, audits, supplier qualification, complaints, recall and risk assessments.
• Proven ability to support inspection readiness, audit preparation and quality system improvement.
• Strong attention to detail, decision-making and organisational skills.
• Excellent written and verbal communication skills.
• Confidence influencing cross-functional stakeholders and senior leaders.
• Practical, solutions-focused mindset with the ability to work effectively in a scale-up environment.

Desirable

• Experience in sterile manufacturing, aseptic processing, biologics, viral vectors, cell and gene therapy, or advanced therapies.
• CDMO or client-facing manufacturing experience.
• Experience with electronic QMS platforms.
• Prior involvement in data integrity programs.
• People leadership or team development experience.

How to Apply

If this opportunity aligns with your experience and career goals, please click ‘Apply Now’ to submit your application.

For a confidential discussion or to learn more, contact Pam Phoumavong at ***email_hidden*** or call 0493 093 532.

About Proclinical

Proclinical is a specialist life sciences recruitment agency, providing job opportunities within leading pharmaceutical, biotechnology, biopharmaceutical, and medical device organisations worldwide. Proclinical Staffing is an equal opportunity employer.