Cqa Vendor Oversight And Quality Assurance Lead (us)

CSL Behring

Fully remote
Glp gcp gmp gvp regulatory adherence
Vendor lifecycle management and qualification
Gxp inspection support and capa management
This role owns the quality oversight of external partners supporting R&D and regulated activities ensuring adherence to global regulations

Job Summary

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

Matching Summary

This role owns the quality oversight of external partners supporting R&D and regulated activities ensuring adherence to global regulations.

Skills & Requirements

Must-have

  • GLP GCP GMP GVP regulatory adherence
  • vendor lifecycle management and qualification
  • GxP inspection support and CAPA management
  • risk-based monitoring strategies
  • quality agreement negotiation

Nice-to-have

  • strong cross-functional collaboration skills
  • experience with multinational teams
  • ability to work with limited supervision
  • excellent communication and negotiation skills

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter