GLP-CQA Manager

2 weeks ago


Somerset, New Jersey, United States Legend Biotech US Full time
Job Title: Manager/Sr. Manager, GLP-CQACompany Information

Legend Biotech is a global biotechnology company dedicated to developing innovative treatments for life-threatening diseases. Our mission is to advance the field of immunotherapy and improve patient outcomes.

Job Summary

We are seeking a highly skilled Manager/Sr. Manager, GLP-CQA to join our Regulatory team in Somerset, NJ. The successful candidate will be responsible for ensuring the quality and compliance of our nonclinical studies, maintaining a compliant quality system, and overseeing the overall laboratory processes.

Key Responsibilities
  • Support the development and implementation of GLP quality compliance systems, including policies and procedures.
  • Manage GLP quality systems, including audits and reviews to ensure compliance.
  • Support the process of GCP/GLP deviations from study protocols or standard operating procedures.
  • Collaborate with cross-functional teams to review relevant data for nonclinical and clinical studies.
  • Provide quality oversight of contract or internal testing facilities to ensure adherence to regulations and standard procedures.
Requirements
  • Education: Bachelor's degree in biology, biochemistry, or the life sciences.
  • Minimum of 3 years (for Sr. Manager) or 1 year (for Manager level) of related industry experience in Quality.
  • 3 years of experience in working and/or overseeing GLP Quality in laboratories testing biologics.
  • Experience performing audits of GLP testing labs and participating in regulatory audits is a plus.
What We Offer

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We offer a competitive salary, comprehensive benefits, and opportunities for professional growth and development.



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