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QA Investigations Lead
4 months ago
Company InformationLegend 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 a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Key ResponsibilitiesSupport compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPsCollaborate with site personnel to provide guidance and determine resolution for manufacturing issuesEnsure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaintsReview and approve manufacturing proceduresSupport regulatory inspections and audits by ensuring inspection readiness within facilityPerform internal housekeeping auditsPerform analysis on quality indicating data and identifying trendsProvide oversight for trending of quality compliance metricsWork in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and PlanningRequirementsA minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is requiredA minimum of 4 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 Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue PracticesGreat attention to detail and ability to follow the proceduresThe candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervisionGood written and verbal communication skills are requiredAbility to summarize and present results, and experience with team-based collaborations is a mustMust be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize riskMust exhibit strong leadership skills and effectively develop othersAbility to collaborate well with stakeholders, customers and peersMust exhibit strong decision-making ability and think creatively while maintaining compliance and qualityMust be able to discern the criticality of issues and to communicate to management regarding complex issuesAbility to manage conflict and issues that arise with internal or external customers#LI-JK1#Li-OnsiteLegend 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.
