Glp Vendor Oversight And Quality Assurance Lead

CSL Behring

Fully remote
Glp/gcp regulatory compliance
Vendor lifecycle management
Risk-based monitoring strategies
CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role involves managing the vendor lifecycle, ensuring compliance with GxP standards, and fostering cross-functional partnerships

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 with a culture focused on inclusion and belonging.

Matching Summary

Match Score: 85

CSL Behring is seeking a GLP Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role involves managing the vendor lifecycle, ensuring compliance with GxP standards, and fostering cross-functional partnerships.

Skills & Requirements

Must-have

  • GLP/GCP regulatory compliance
  • Vendor lifecycle management
  • Risk-based monitoring strategies
  • Quality agreement negotiation
  • CAPA implementation and verification
  • Data integrity ALCOA+ principles

Nice-to-have

  • Cross-functional collaboration skills
  • Continuous improvement drive
  • Multinational team experience
  • Strong analytical problem solving
  • Effective communication and negotiation

Key Requirements

  • Bachelor's degree in scientific discipline
  • 3+ years GxP quality experience
  • Direct vendor/CRO/CMO oversight experience
  • Knowledge of ICH, OECD GLP, FDA, EMA regulations
  • Experience with audit and inspection management

Work Rights

Not specified

Tailored Resume

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