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    Quality Compliance Lead

    Legend Biotech Us
    6+ years
    Not Disclosed
    Raritan
    10 July 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Quality Compliance Lead

    Company: Legend Biotech

    Location: Raritan, NJ

    Company Information:

    Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Somerset, New Jersey, Legend Biotech develops advanced cell therapies across various technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapy.

    In 2017, Legend Biotech entered into a global collaboration agreement with Janssen, a pharmaceutical company under Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) for the treatment of multiple myeloma. This strategic partnership combines the strengths and expertise of both companies to advance the promise of immunotherapy.

    Role Overview:

    The Quality Compliance Lead Auditor for CAR-T is responsible for ensuring regulatory compliance in the production of autologous CAR-T products for clinical trials and commercial operations within a controlled cGMP cleanroom environment.

    Key Responsibilities:

    • Internal Audit Process: Support the implementation, execution, and improvement of the internal audit process.
    • Audit Execution: Plan and execute internal audits for all quality system areas at the manufacturing site; write audit reports, issue audit observations, and follow through to ensure satisfactory resolution and closure of each internal audit.
    • Audit Coordination: Coordinate front room/back room activities for health authority audits and independent audits; manage audit responses and observation resolution.
    • Compliance: Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions to meet unified business objectives.
    • Data Analysis: Run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of compliance data for monthly CRB and quarterly QSMR presentations.
    • Audit Module Responsibilities: Fulfill the Quality System audit module site key user responsibilities; represent the Raritan site in global forums/team meetings, mentor site users for audit processes, and control access to any systems used to support audits/inspections.
    • Support Quality Systems: Provide support to the quality systems team for activities such as annual product review, site risk register, or internal quality agreements.
    • Training: Develop and deliver training for specific quality system topics in both classroom settings and individual interactions.
    • Corrective Actions: Support the creation, assessment, and closure of corrective actions, change controls, or audit actions related to the site.
    • Inspection Readiness: Ensure and maintain a state of inspection readiness. Perform compliance walkthroughs as part of audit/inspection readiness activities.
    • Safety and cGMP Compliance: Perform tasks consistent with safety policies, quality systems, and cGMP requirements.

    Requirements:

    • Education: Minimum of a Bachelor's Degree in Engineering, Science, or equivalent technical discipline.
    • Experience: Minimum of six (6) years of experience in Quality Assurance/Quality Systems or Compliance, with at least four (4) years within laboratories or laboratory oversight.
    • Auditing: Experience conducting internal audits (self-inspection), including writing audit reports, writing observations, and follow-through of observation resolution.
    • External Audits: Experience in front room/back room roles for external audits.
    • Quality Systems: Experience working with quality systems is required.

    Employment Information:

    • Equal Opportunity Employer: Legend Biotech is committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Legend Biotech ensures 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.
    • Drug-Free Workplace: Legend Biotech maintains a drug-free workplace.

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