Glp Vendor Oversight And Quality Assurance Lead

Century Center

Fully remote
Glp/gcp regulatory compliance expertise
Vendor lifecycle management experience
Risk-based monitoring strategies
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories

Job Summary

  • This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories.
  • The position requires leading the end-to-end vendor lifecycle from due diligence to continuous improvement while ensuring adherence to GLP/GCP regulations.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and a culture of inclusion.

Matching Summary

This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs and laboratories.

Skills & Requirements

Must-have

  • GLP/GCP regulatory compliance expertise
  • Vendor lifecycle management experience
  • Risk-based monitoring strategies
  • Quality agreement negotiation skills
  • GxP audit and inspection support

Nice-to-have

  • Strong cross-functional collaboration abilities
  • Data integrity ALCOA+ knowledge
  • Experience with multinational teams
  • Continuous improvement drive
  • Excellent communication and influencing skills

Key Requirements

  • Bachelor's degree in relevant scientific discipline
  • 3+ years of GxP quality experience
  • Direct vendor/CRO/CMO oversight or auditing background
  • Knowledge of ICH, OECD GLP, FDA, EMA regulations
  • Up to 50% travel required

Work Rights

Not specified

Tailored Resume

Cover Letter