We are seeking an experienced Auditor – Supplier Quality Management to join our APAC External Supplier Quality team.
This role is pivotal in ensuring that external suppliers and service providers across the region operate in full compliance with global regulatory requirements and CSL quality standards. You will provide expert quality oversight, identify and mitigate supplier‑related risks, and support continuous improvement across the supplier network.
Working with a high degree of autonomy, you will collaborate closely with internal stakeholders and external partners to ensure product quality, supply continuity, and inspection readiness.
This role will require approximately 50% travel and will be primarily based in Tullamarine. However, frequent travel to other sites, including Broadmeadows and Melbourne, will also be expected.
Key Responsibilities
Plan, conduct, and lead supplier quality system audits across raw materials, components, CMOs, laboratories, distributors, and service providers.
Support supplier qualification, enrolment, and requalification, including audit preparation, reporting, and evaluation of corrective actions.
Establish, negotiate, and maintain Quality Agreements with external suppliers.
Perform ongoing supplier risk assessments, update risk ratings in eQMS systems, and support risk‑based supplier oversight.
Provide quality oversight and support for supplier deviations, investigations, complaints, material onboarding and material changes, and CAPAs.
Act as a liaison between suppliers and CSL sites to resolve quality issues and ensure timely mitigation of supply risk.
Maintain accurate supplier quality documentation, including Approved Supplier Lists and quality records.
Support regulatory inspections and audits, providing subject‑matter expertise to sites and global teams.
Contribute to enterprise harmonization initiatives and continuous improvement of supplier quality processes.
About You
Qualifications & Experience
Bachelor’s degree in a scientific or relevant discipline (or equivalent experience).
5 years plus experience working in a GxP‑regulated pharmaceutical or biotech environment.
Strong experience in supplier auditing and quality systems.
In‑depth knowledge of global cGMP regulations and international health authority requirements (e.g. FDA, EMA, PIC/S, TGA).
Experience with sterile manufacturing, biological products, or laboratory operations is highly desirable.
Capabilities
Strong audit, risk assessment, and problem‑solving skills.
Confident communicator, able to engage effectively with internal stakeholders and external suppliers.
Demonstrated ability to work independently, manage multiple priorities, and exercise sound quality judgment.
Collaborative mindset with a strong focus on continuous improvement and accountability.
