QA Document Control Lead (1st shift, M-F)

Company Information

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 QA Document Control Leadas part of the Quality team based in Raritan, NJ.

Role Overview

The QA Document Control Lead role is an exempt level position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.

Key Responsibilities

• Day to day management of resources, planning and assigning work to Document Control Specialists to meet goals and deadlines.
• Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures as needed.
• Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments.
• Support Document Management system users with workflow handling and electronic system usage, as needed.
• Manage the periodic review process for procedures, as needed.
• Issue batch related documentation and labels in support of GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Create and issue GMP logbooks.
• Responsible for storage and archival of GMP documents and batch related records.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Drive continuous improvement.
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.

Requirements

• A minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• A minimum of a Bachelor's Degree in Science, Information Science or equivalent is required.

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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.