Associate Manager, QA Shop Floor
Confirmed live in the last 24 hours
Legend Biotech
Compensation
$75,972 - $99,713/year
Job Description
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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
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). 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 Manager, QA Shop Floor as part of the Quality team based in Raritan, NJ.
Role Overview
The Associate Manager, QA Shop Floor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.
Key Responsibilities
- Read, interpret, and revise documents such as SOPs, work instructions.
- Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
- Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
- Independently makes appropriate and compliant GMP decisions.
- Independently resolves problems using quality systems.
- Lead quality driven continuous improvement projects.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Support QASF team growth and development.
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