About The Position
We are seeking a Vendor / Supplier R&D Quality Assurance professional to provide quality oversight of external partners supporting CSL’s R&D and regulated activities, including CROs, CMOs, laboratories, and technology vendors. This role is responsible for managing the end‑to‑end vendor lifecycle, ensuring third‑party services meet applicable GCP, GMP, and GVP requirements, data integrity standards, and regulatory expectations. You will partner closely with Clinical, non‑Clinical, CMC, Safety, Procurement, Legal, and IT teams to enable compliant and reliable delivery from external partners and will be based at our Elizabeth street Melbourne office. This role will require 50% of travel around APAC.
Requirements
- Bachelor’s degree in a relevant scientific discipline
- 3+ years’ experience in GxP Quality with direct vendor/CRO/CMO oversight or auditing
- Working knowledge of GLP/GCP/GMP/GVP, ICH guidelines, FDA/EMA expectations, and data integrity (ALCOA+)
- Experience supporting or leading audits and inspections
- Strong analytical, problem‑solving, and risk‑based decision‑making skills
- Excellent communication, influencing, and negotiation capabilities
- Comfortable working independently in a global, cross‑functional environment
- Strong organisational skills with the ability to manage multiple priorities
- Collaborative, pragmatic, and improvement‑focused approach
Responsibilities
- Lead vendor qualification, re‑qualification, and governance activities using risk‑based approaches
- Develop, negotiate, and maintain Quality Agreements aligned with commercial contracts
- Plan and support GxP audits and inspections of CROs, vendors, and service providers
- Review audit findings and oversee CAPA development and effectiveness checks
- Monitor vendor performance through KPIs, SLAs, dashboards, and periodic reviews
- Support deviations, change controls, complaints, and CAPAs involving third parties
- Maintain vendor risk assessments and drive continuous improvement initiatives
- Act as a key QA partner across Clinical, CMC, Safety, Procurement, Legal, and IT
- Maintain current knowledge of GxP regulations, data integrity, and industry trends
Benefits
- How CSL Supports Your Well-being
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What This Job Offers
Job Type
Full-time
Career Level
Senior
