Quality Specialist

Quality Systems & Operations Specialist

Location: North Sydney, NSW

Hybrid working, 2-3 days per week in office.

We are currently partnering with a growing pharmaceutical organisation to recruit a Quality Systems & Operations Specialist for their Sydney-based team. This is a newly created role, offering the opportunity to contribute to a business entering an exciting phase of expansion, with a robust pipeline of innovative oncology and haematology products scheduled for launch over the coming years.

The successful candidate will play a pivotal role in enhancing quality systems, supporting compliance across key operational functions, and providing oversight of supply chain activities. This is a hands-on position suited to a mid-level professional who thrives in a dynamic, fast-paced environment and is eager to help shape the operational foundations of a growing organisation.

Key Responsibilities:

• Maintain and improve the local Quality Management System (QMS)
• Develop and implement SOPs aligned with global standards
• Ensure compliance with GDP and relevant regulatory requirements
• Work closely with pharmacovigilance, regulatory, and medical information functions
• Lead or support the implementation of global systems locally
• Monitor supply chain activities for compliance with quality standards
• Liaise with internal and external stakeholders to ensure product integrity

Candidate Profile:

• Bachelor’s degree in a scientific discipline
• Demonstrated experience in pharmaceutical quality roles
• Experience within an affiliate setting would be beneficial
• Exposure to supply chain operations and system implementations
• Strong understanding of GDP, QMS, and regulatory frameworks in Australia
• Proactive, solutions-focused, and adaptable to change
• Comfortable working in a lean, agile environment

This is a rare opportunity to join a business at a formative stage, where your contributions will directly influence the development of quality and operational frameworks. If you’re looking for a role with impact, autonomy, and the chance to grow alongside a high-performing team, I would love to hear from you.

To learn more, please email Principal Consultant Maeve Fahey with your resume; mfahey@i-pharmconsulting.com.