Outstanding career opportunity in pharmaceutical quality

Medicines Development for Global Health – Southbank VIC

As the responsible person for Quality at MDGH, you will manage the MDGH Quality System across regulated activities (GxP), with particular focus on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Working closely with our CMC, Regulatory and Clinical teams, external vendors and network of consultants, you will provide quality expertise and guidance while actively managing and delivering quality activities. You will promote a strong quality culture and ensure our development activities meet applicable quality and regulatory requirements.

Key responsibilities

Manage and maintain the MDGH Quality System, including the development, review and maintenance of SOPs, working practices, GxP training, document control, CAPA and change control.

Provide quality leadership and advice across MDGH and actively manage quality issues, identifying and escalating quality risks, and preparing and providing regular Quality Management Reviews to senior management.

Lead the internal and external audit program, vendor assurance activities and preparation for, support of and responses to regulatory inspections.

Manage quality activities supporting CMC, including quality agreements, vendor and CMO performance, deviations and investigations, technical audits, and review and approval of manufacturing and laboratory records.

Manage quality activities supporting clinical development, including CRO and vendor quality matters, clinical trial master file audits and clinical site audits.

Monitor quality data and trends, initiate and drive effective corrective actions and continuous improvement activities,



and work collaboratively across functions to maintain a strong culture of quality and compliance.

About you

At least five years' direct experience in a quality role.

Excellent working knowledge of Quality Management Systems.

Knowledge of relevant GxP regulatory requirements, particularly GMP and/or GCP.

A degree in a science discipline, preferably chemistry, biology or microbiology.

A relevant postgraduate qualification in quality, research and/or pharmaceutical development well regarded.

Experience in a GMP pharmaceutical manufacturing environment and/or clinical operations highly regarded.

Practical, solutions-focused approach with excellent communication and organisational skills.

Solid attention to detail and willingness to learn and grow.

About us

Medicines Development for Global Health (MDGH) develops medicines to ease the burden of neglected diseases on underserved communities worldwide. Our approach is to bring together the ideas of researchers with our development expertise and passion to develop new products that will be life changing for millions. We are a non-profit company with an innovative funding model - all funds in excess of expenses are devoted to this purpose. Our team brings a depth of expertise from within the pharmaceutical and global health sectors in clinical studies, project management, pharmaceutical development, regulatory submissions and medicines access.

Flexible hybrid working, recognising the value of both focused individual work and effective collaboration with colleagues and partners.

Competitive market-based salary package, including fringe benefits which are tax exempt for Australian based staff.

Friendly, inclusive team committed to making a difference with strong focus on employee well-being and professional growth and development.

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📌 Outstanding career opportunity in pharmaceutical quality (Melbourne)
🏢 Medicines Development for Global Health
📍 Melbourne