Glp Vendor Oversight And Quality Assurance Lead

CSL Ltd

PA, United States
On-site
Glp/gcp compliance
Data integrity principles
Risk-based vendor monitoring
CSL Ltd is seeking a GLP Vendor Oversight and Quality Assurance Lead to manage quality oversight of external partners involved in R&D and regulated activities. The role requires expertise in vendor lifecycle management, compliance with GLP/GCP standards, and collaboration across various teams

Job Summary

  • The GLP Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated activities.
  • Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP, data integrity and applicable regulations.
  • This role partners closely with Research, Clinical, Nonclinical, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties.

Matching Summary

Match Score: 85

CSL Ltd is seeking a GLP Vendor Oversight and Quality Assurance Lead to manage quality oversight of external partners involved in R&D and regulated activities. The role requires expertise in vendor lifecycle management, compliance with GLP/GCP standards, and collaboration across various teams.

Skills & Requirements

Must-have

  • GLP/GCP compliance
  • Data integrity principles
  • Risk-based vendor monitoring
  • Vendor lifecycle management
  • Quality Agreements
  • GxP audits

Nice-to-have

  • Cross-functional collaboration
  • Continuous improvement initiatives
  • Regulatory trend analysis

Key Requirements

  • Bachelor’s degree in relevant scientific discipline
  • 3+ years of GxP quality experience
  • Direct vendor/CRO/CMO oversight and/or auditing
  • Knowledge of ICH, OECD GLP, FDA, EMA, EU Annex 11/21 CFR Part 11
  • Data integrity (ALCOA+)
  • Audit/inspection management experience

Work Rights

Not specified

Tailored Resume

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