US: Sr. Quality Compliance Lead

3 days ago

Raritan, United States TBWA\Chiat\Day Full time

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 Sr. Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Key Responsibilities Successfully support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through to ensure satisfactory resolution and closure of each internal audit. Coordinate front room/ back room activities for health authority audits and independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions, to meet unified business objectives. As required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of compliance data for the monthly CRB & quarterly QSMR presentations. Fulfills the Quality System audit module site key user responsibilities - represent the Raritan site in global forums/ team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections. Provide support to quality systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements. Develops and delivers training for specific quality system topics, in both classroom setting and individual interactions. Support the creation, assessment and closure as needed of corrective actions, change controls, or audit actions related to the site. Ensures and maintains a state of inspection readiness. Perform compliance walkthroughs as part of audit/inspection readiness activities to ensure that the site is in an inspection ready state. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Requirements A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required. A minimum of six (6) years of experience in Quality Assurance/Quality Systems or Compliance with a minimum of 4 of those within laboratories or laboratory oversight. Experience conducting internal audits (self-inspection), including writing audit reports, writing observations, and follow-through of observation resolution. Experience in front room/back room roles for external audits. Experience working with quality systems is required. #J-18808-Ljbffr

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