Senior Quality Associate - Preclinical & Laboratory Quality

CSL Behring

Base: $94,000 - $111,000; bonus/equity: incentive ...
Not specified
Knowledge of oecd principles of glp
Experience with iso/iec 17025 requirements
Minimum 3 years in glp/gxp environments
CSL Behring is seeking a Senior Quality Associate to ensure compliance with GLP, GCLP, and other GxP requirements in their Preclinical and Laboratory Quality divisions. The role involves supporting quality systems, managing inspections, and promoting a strong quality culture within the organization

Job Summary

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

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Quality Associate to ensure compliance with GLP, GCLP, and other GxP requirements in their Preclinical and Laboratory Quality divisions. The role involves supporting quality systems, managing inspections, and promoting a strong quality culture within the organization.

Salary

Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Refer to CSL benefits documentation for details

Skills & Requirements

Must-have

  • Knowledge of OECD Principles of GLP
  • Experience with ISO/IEC 17025 requirements
  • Minimum 3 years in GLP/GxP environments
  • Review and approve study protocols and reports
  • Lead facility and document inspections

Nice-to-have

  • Strong planning and organizational skills
  • Commitment to continuous improvement
  • Good presentation and negotiation skills
  • Strong customer focus
  • Ability to model CSL Way values

Key Requirements

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

Work Rights

Not specified

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