Sr. Manager, Cqa Glp

Legend Biotech

Somerset, New Jersey, United States
On-site
Glp quality compliance systems management
External vendor audit execution and reporting
Sop development and laboratory process oversight
The role involves ensuring nonclinical studies are performed in strict compliance with GLP regulations and Health Authorities' guidance

Job Summary

  • The role involves ensuring nonclinical studies are performed in strict compliance with GLP regulations and Health Authorities' guidance.
  • The incumbent will oversee the overall laboratory processes by reviewing and supporting the development of SOPs and bioanalytical assays.
  • This position requires maintaining a compliant quality system to meet inspection-readiness goals through rigorous vendor audits and data review.

Matching Summary

The role involves ensuring nonclinical studies are performed in strict compliance with GLP regulations and Health Authorities' guidance.

Skills & Requirements

Must-have

  • GLP quality compliance systems management
  • External vendor audit execution and reporting
  • SOP development and laboratory process oversight
  • Data integrity verification for nonclinical studies
  • Cross-functional collaboration with study teams

Nice-to-have

  • Experience with GCP/ICH guidelines application
  • Familiarity with Veeva system documentation
  • Knowledge of biologics testing laboratories
  • Strong communication in English language

Key Requirements

  • Bachelor's degree in biology, biochemistry, or life sciences
  • 3 years of experience in GLP Quality for biologics laboratories
  • Minimum 3 years of related industry experience in Quality for Sr. Manager level

Work Rights

Not specified

Tailored Resume

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