GLP-CQA Manager
2 weeks ago
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 SummaryWe 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.
- 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.
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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