Senior Quality Associate - Preclinical & Laboratory Quality

cslbehring.cz

Base: $94,000 - $111,000; bonus/equity: incentive ...
Glp and gclp regulatory compliance
Iso/iec 17025 testing standards
Oecd principles of good laboratory practice
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 requirements while supporting the implementation of quality initiatives across R&D functions

Job Summary

  • This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 requirements while supporting the implementation of quality initiatives across R&D functions.
  • The position involves leading inspection readiness activities, managing regulatory inspections, and overseeing corrective and preventive actions to ensure timely resolution of findings.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture that values inclusion, belonging, and innovation.

Matching Summary

This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 requirements while supporting the implementation of quality initiatives across R&D functions.

Salary

Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • GLP and GCLP regulatory compliance
  • ISO/IEC 17025 testing standards
  • OECD Principles of Good Laboratory Practice
  • CAPA management and resolution
  • Regulatory inspection readiness

Nice-to-have

  • Strong planning and organizational skills
  • Commitment to continuous improvement
  • Global harmonized quality strategies
  • Effective stakeholder negotiation skills

Key Requirements

  • BS Degree in biological science or related discipline
  • Minimum 3 years experience in GLP/GxP laboratories or QA
  • Knowledge of OECD GLP principles and ISO 17025

Work Rights

Not specified

Tailored Resume

Cover Letter