Title:  Quality Specialist - Healthcare

Quality Specialist – Healthcare  

📍 Sydney 

Join DKSH Healthcare and take ownership of product quality across ANZ. This role is key to ensuring compliant product release, leading supplier audits, and strengthening our Quality Management System. 

About the role 

As the Quality Specialist, you will lead oversight of product quality across DKSH Healthcare ANZ, working closely with internal teams and external partners to ensure regulatory compliance and continuous improvement. 

What you’ll do 

• Be responsible for overall product quality across DKSH Healthcare ANZ  

• Support and/or perform quality release activities and release recommendations in accordance with GDP/GMP and sponsor requirements 

• Act as a key Quality representative during audits and regulatory inspections including conducting periodic onsite and virtual supplier audits  

• Support responses to audit observations and ensure timely, effective CAPA implementation and closure 

• Author and maintain SOPs within the Quality Management System (QMS)  

• Drive continuous improvement initiatives across the QMS 

• Uphold and promote high standards of regulatory compliance and product quality across the organisation 

• Own and maintain key elements of the Quality Management System, including SOP review cycle management and the Quality Manual 

• Proactively identify and escalate quality risks to leadership and recommend mitigation strategies 

About you 

• Strong understanding of regulatory requirements in Australia and New Zealand 

• 4–5 years’ experience in Quality, particularly in Product Quality & Release or Distribution Quality roles  

• In-depth knowledge of Good Distribution Practice (GDP) and/or Good Manufacturing Practice (GMP)  

• Experience working with healthcare distributors, sponsors, or pharmaceutical companies 

• Proven experience working within a Quality Management System (QMS)  

• Handson experience supporting audits and regulatory inspections  

• Confident communicator with a proactive, solutions focused mindset 

• Degree in Pharmacy or a Biosciences discipline (preferred)  

Why join? 

• High impact role with true end-to-end quality ownership  

• Opportunity to work within a global, growing healthcare organisation  

• Collaborative, purpose driven team environment  

• Supporting, high-performing team within a Great Place to Work-certified organisation