Glp Vendor Oversight And Quality Assurance Lead

CSL

PA, United States
On-site
Glp/gcp vendor oversight
Quality agreements negotiation
Risk-based monitoring
The GLP Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated activities

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.
  • This role partners closely with Research, Clinical, Nonclinical, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties.
  • Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.

Matching Summary

The GLP Vendor Oversight and Quality Assurance Lead role will own the quality oversight of external partners supporting R&D and regulated activities.

Skills & Requirements

Must-have

  • GLP/GCP vendor oversight
  • Quality agreements negotiation
  • Risk-based monitoring
  • GxP audits and CAPA management
  • Data integrity principles (ALCOA+)

Nice-to-have

  • Cross-functional collaboration
  • Continuous improvement initiatives
  • Global team collaboration

Key Requirements

  • 3+ years of GxP quality experience
  • Direct vendor/CRO/CMO oversight and/or auditing
  • Bachelor’s degree in relevant scientific discipline

Work Rights

Not specified

Tailored Resume

Cover Letter