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QA Investigations Supervisor (2nd shift)
Location:
Raritan
Description:
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 Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations Supervisor 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 managing Quality Leaders and approving critical site nonconformance investigations, owning projects related to Quality, and tracking of quality metrics while ensuring high quality and compliant product supply. This position will have direct reports. Key Responsibilities Supervise a team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily touch point meetings with the team and monitor workload. Lead the daily triage meeting for nonconformance initiation. Support the Quality Leaders in meetings with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Approve the change in scope or level of an investigation. Perform timely escalations of potential significant quality issues to management. Escalate to management about issues delaying product release or investigation closure. Monitor timely completion of batch release related impact assessments. Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs. Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Review critical level investigations and supporting corrections and CAPAs. Lead continuous improvement associated with investigation management. Support regulatory inspections and audits by ensuring inspection readiness within facility. Provide oversight for trending of quality compliance metrics. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 5 years relevant work experience is required. Candidate must have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy . A minimum of 2 years' experience managing a team of at least 3 reports. Knowledge of Nonconformance and CAPA management process. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability 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.
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