Global GLP Vendor QA & Compliance Lead

CSL; Melbourne; On-site; AUD 140,000 - 210,000; Full time

Job summary

CSL in Melbourne seeks an experienced GLP Vendor Oversight and QA Lead to safeguard data integrity across nonclinical studies. You will own external partner quality, from due diligence and qualification to CAPA and governance, ensuring GLP/GCP/GMP compliance.

You will collaborate with Nonclinical Development, Procurement, Legal and IT to embed quality in contracts, drive risk-based monitoring, audits and continuous improvement, translating regulatory changes into CSL requirements.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing.
• Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+).
• Strong communication and negotiation skills.
• Cross-functional collaboration across multinational teams.

Responsibilities

• Vendor lifecycle governance: qualification, quality agreements, KPIs and CAPA closure.
• Inspections: plan, execute and assess vendor audits and readiness.
• Quality systems: ensure GLP/GXP compliance and data integrity.
• Risk management: conduct vendor risk assessments and continuous improvement.
• Cross-functional partnership: embed quality in scopes of work and contracts.
• Regulatory knowledge: stay current with GLP and GxP regs and CSL requirements.

Skills

Vendor governance

Vendor audits

Quality systems

Risk management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in a relevant scientific discipline

Job description

CSL in Melbourne seeks an experienced GLP Vendor Oversight and QA Lead to safeguard data integrity across nonclinical studies. You will own external partner quality, from due diligence and qualification to CAPA and governance, ensuring GLP/GCP/GMP compliance.

You will collaborate with Nonclinical Development, Procurement, Legal and IT to embed quality in contracts, drive risk-based monitoring, audits and continuous improvement, translating regulatory changes into CSL requirements.