Benefits
• Permanent, full-time opportunity
• Broad, hands-on role with real ownership and visibility
• Collaborative, small-team environment with exposure across the business
About the company
This opportunity sits within a growing, specialty pharmaceutical organisation operating across Australia and New Zealand. The business focuses on the commercialisation and distribution of medicines across several therapeutic areas. Locally, the team is lean, agile, and in a growth phase, offering genuine influence and autonomy.
About the opportunity
This is a newly created Quality and Medical Operations Specialist role. The position offers broad responsibility across quality systems, pharmacovigilance, and medical, making it ideal for someone who enjoys being hands-on and building structure in a growing organisation. You will play a key role in ensuring compliance with TGA, GMP, and PV requirements while partnering closely with regulatory, commercial, and external stakeholders.
Duties
• Own and manage the local QMS including document control, deviations, change control, CAPAs, and continuous improvement activities
• Manage product quality complaints, adverse quality events, and investigations in line with TGA expectations
• Coordinate quality documentation for imported products, manufacturers, suppliers, and distributors
• Act as the local QPPV overseeing adverse event reporting and pharmacovigilance obligations
• Submit adverse events to the TGA and maintain an effective PV system
• Support readiness for TGA audits and inspections, including preparation and follow-up actions
• Develop, review, and maintain SOPs, work instructions, and quality policies
• Partner with Sales and Marketing teams to embed quality processes into commercial activities
• Support medical information activities over time, with structured training provided
• Collaborate with Regulatory Affairs on GMP clearances, product changes, and quality-related submissions
Skills and experience
• Tertiary qualification in Pharmaceutical Sciences, Quality Assurance, or a related discipline
• Experience working within a pharmaceutical Quality Management System
• Solid understanding of TGA, GMP, and PV requirements in a commercial environment
• Experience developing and maintaining SOPs and quality documentation
• Strong attention to detail with a practical, solutions-focused mindset
• Comfortable working autonomously and building processes where they do not yet exist
• Confident communicator able to engage across technical and non-technical stakeholders
Culture
This organisation offers a down-to-earth, collaborative culture where people are trusted to take ownership.
How to apply
If this sounds like your next move, click apply or for a confidential discussion.
About Healthcare Professionals Group
Healthcare Professionals Group recruits across Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care, spanning Medical Affairs, Regulatory Affairs, Quality, Pharmacovigilance, Commercial, and Operations roles.