Senior Quality Associate - Preclinical & Laboratory Quality

cslbehring.de

Base: $94,000 - $111,000; bonus/equity: incentive ...
Glp and gclp compliance knowledge
Iso/iec 17025 testing standards
Oecd principles of glp application
This role ensures compliance with GLP, GCLP, ISO/IEC 17025, and other GxP requirements across R&D preclinical and clinical lab functions

Job Summary

  • This role ensures compliance with GLP, GCLP, ISO/IEC 17025, and other GxP requirements across R&D preclinical and clinical lab functions.
  • The position involves leading inspection readiness activities, managing regulatory inspections, and resolving findings through corrective and preventive actions.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, employing over 32,000 people in more than 100 countries.

Matching Summary

This role ensures compliance with GLP, GCLP, ISO/IEC 17025, and other GxP requirements across R&D preclinical and clinical lab functions.

Salary

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

Skills & Requirements

Must-have

  • GLP and GCLP compliance knowledge
  • ISO/IEC 17025 testing standards
  • OECD Principles of GLP application
  • CAPA management and resolution
  • Regulatory inspection readiness

Nice-to-have

  • Strong planning and organizational skills
  • Commitment to continuous improvement
  • Excellent negotiation and decision-making
  • Global harmonized quality strategies
  • Collaborative stakeholder engagement

Key Requirements

  • BS Degree in biological science or related discipline
  • Minimum 3 years experience in GLP/GxP laboratories
  • Experience in R&D Quality or product development teamwork

Work Rights

Not specified

Tailored Resume

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