Product Quality & Compliance Lead

DKSH; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

DKSH is seeking a Quality Specialist to oversee product quality across DKSH Healthcare ANZ in Sydney. The role ensures regulatory compliance and drives continuous improvement within the Quality Management System.

You will lead quality release activities, support supplier audits, and act as the Quality representative during regulatory inspections, with a focus on GDP/GMP and end-to-end quality ownership across the organization.

Qualifications

• 4–5 years’ experience in Quality, particularly in Product Quality & Release or Distribution Quality
• In-depth knowledge of GDP and/or GMP
• Experience with healthcare distributors, sponsors, or pharmaceutical companies
• Hands-on experience supporting audits and regulatory inspections
• Degree in Pharmacy or biosciences preferred

Responsibilities

• Oversee product quality across DKSH Healthcare ANZ
• Support quality release activities and recommendations per GDP/GMP
• Act as Quality representative during audits and regulatory inspections
• Support responses to audit observations and ensure CAPA closure
• Author and maintain SOPs within the Quality Management System (QMS)
• Drive continuous improvement initiatives across the QMS
• Uphold high standards of regulatory compliance and product quality
• Own and maintain key elements of the QMS including SOP review cycles and Quality Manual
• Identify and elevate quality risks to leadership and recommend mitigations

Skills

Regulatory knowledge

Quality management

Audit readiness

CAPA management

GDP knowledge

Education

Bachelor of Pharmacy

Tools

QMS software

Job description

DKSH is seeking a Quality Specialist to oversee product quality across DKSH Healthcare ANZ in Sydney. The role ensures regulatory compliance and drives continuous improvement within the Quality Management System.

You will lead quality release activities, support supplier audits, and act as the Quality representative during regulatory inspections, with a focus on GDP/GMP and end-to-end quality ownership across the organization.