Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based in Raritan, NJ.
Role Overview
The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all applicable regulations and organizational performance objectives.
The incumbent will be responsible for providing oversight and co-leadership of the investigation management system, including technical and performance oversight, co-managing investigation teams in a matrix organization, and driving continuous improvement initiatives to enhance investigation quality, timeliness, and productivity.
Key Responsibilities
Co-Lead Deviation Investigations:
Provide Technical Oversight:
Investigation Team Management:
Risk Assessment and Prioritization:
CAPA Management:
Performance Monitoring, Reporting and Management:
Resource Co-management:
Continuous Improvement Initiatives:
Stakeholder Engagement:
Training and Development:
Requirements
#Li-Onsite
#Li-JK2
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
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