Glp Vendor Oversight And Quality Assurance Lead

CSL Behring

PA, United States
**
Glp/gcp vendor oversight
Quality agreements
Risk-based monitoring
** The GLP Vendor Oversight and Quality Assurance Lead position at CSL Behring involves overseeing the quality of external partners supporting R&D and regulated activities. The role requires extensive experience in GxP quality oversight, vendor management, and compliance with relevant regulations. The ideal candidate will have strong communication skills and the ability to collaborate with various cross-functional 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: 75

** The GLP Vendor Oversight and Quality Assurance Lead position at CSL Behring involves overseeing the quality of external partners supporting R&D and regulated activities. The role requires extensive experience in GxP quality oversight, vendor management, and compliance with relevant regulations. The ideal candidate will have strong communication skills and the ability to collaborate with various cross-functional teams. **

Skills & Requirements

Must-have

  • GLP/GCP vendor oversight
  • Quality agreements
  • Risk-based monitoring
  • GxP audits
  • Data integrity principles

Nice-to-have

  • Cross-functional partnership
  • Continuous improvement initiatives
  • Regulatory knowledge upkeep

Key Requirements

  • 3+ years GxP quality experience
  • Direct vendor/CRO/CMO oversight
  • ICH, OECD GLP, FDA, EMA knowledge
  • Data integrity (ALCOA+) knowledge
  • Bachelor’s degree in relevant scientific discipline

Work Rights

Not specified

Tailored Resume

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