Quality Specialist (Sydney - Hybrid)

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

JoinDKSH Healthcareand 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 willlead 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 foroverall product quality across DKSH Healthcare ANZ

Support and/or perform quality release activities and release recommendationsin accordance withGDP/GMP and sponsor requirements

Act as a key Quality representativeduring audits andregulatoryinspectionsincludingconducting periodic onsite and virtual supplier audits

Support responses to audit observations and ensuretimely, effective CAPA implementation and closure

Author andmaintainSOPs within the Quality Management System (QMS)

Drive continuous improvement initiatives across the QMS

Uphold and promotehigh standardsof regulatory compliance and product quality across the organisation

Own andmaintainkey elements of the Quality Management System, including SOP review cycle management and the Quality Manual

Proactivelyidentifyand elevatequality 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)

Hands on experience supporting audits and regulatory inspections

Confident communicator with a proactive, solutionsfocusedmindset

Degree in Pharmacy or a Biosciences discipline (preferred)

Highimpact role with trueend-to-endquality ownership

Opportunity to work within a global, growing healthcare organisation

Collaborative, purposedriven team environment

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