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Senior qc supervisor

Gand
Legend Biotech
Publiée le 13 septembre
Description de l'offre

Senior QC Supervisor – CAR T ManufacturingAre you passionate about playing a key role in the production of life-saving cell therapies? Join us as a Senior QC Supervisor in CAR T Manufacturing, you will play a pivotal role in the production of life-saving, personalized cell therapies. You'll be part of a dynamic team in a state-of-the-art GMP facility where innovation meets impact, and your leadership directly contributes to delivering hope to patients worldwide.This is more than a job — it's a purpose. You'll be leading a team that ensures rigorous in-process quality control (IPL), environmental monitoring, and seamless sample handling in support of both clinical trials and commercial manufacturing. Your expertise will uphold the highest standards of compliance, excellence, and efficiency in a rapidly growing biotech environment.This position requires shift work.What can you expect?A high-impact leadership role in a cutting-edge CAR T cell therapy facilityAn opportunity to shape and develop a growing QC teamCross-functional collaboration across manufacturing, quality, and technical operationsInvolvement in strategic planning and continuous improvement initiativesA chance to contribute to life-changing therapies and be part of a patient-focused missionA workplace culture rooted in collaboration, quality, and accountabilityHere's what you'll do:Daily OperationsOversee QC operations related to in-process testing and environmental monitoring (EM)Create and coordinate shift schedules with QC schedulers and supervisorsAct as GMP decision-maker and liaise with QA and operational teamsManage and escalate issues impacting product release timelinesInitiate and support non-conformance investigations and CAPA activitiesAssist in capacity planning and budget forecastingContribute to organizational strategy and team optimizationPeople & Cross functional collaborationLead daily meetings and foster a culture of engagement and accountabilityRecruit, coach, and develop QC analysts and QC support techniciansBuild strong cross-functional relationships across Quality, IT, Maintenance, Manufacturing, and others. Act as back-up for the (Senior) QC Manager as neededOperational Excellence & ProjectsDrive data collection and performance analysis for IPL, EM, and sample transportDefine and track key performance indicators (KPIs)Lead and implement improvement projects from concept to completionSupport cross-functional initiatives via change management processesQuality & ComplianceAct as QC SME in reviews and audits; prepare for inspectionsSupport risk assessments and ensure training complianceStay current with evolving regulations and best practicesUphold GMP and regulatory standards at all timesWho are we looking for?A proactive, detail-oriented leader with a deep understanding of GMP and QC operations in a cell therapy or biopharmaceutical environment. You have a passion for people development, operational excellence, and scientific integrity. You thrive in fast-paced, high-stakes environments and are confident in making data-driven decisions while leading a team with empathy and precision.Education:Bachelor’s degree (or higher) in Science, Engineering, or a related technical disciplineEquivalent experience in the biotech/pharmaceutical industry will be consideredExperience:Minimum 7 years of relevant work experience in a GMP or ATMP lab environmentAt least 4 years in Quality Control, with preference for aseptic manufacturing experience5+ years in leadership roles, with experience in team development and performance managementLanguages:Fluent in Dutch and English, both written and spokenStrengths:Strong communicator and team builderResilient and adaptable under shifting prioritiesHighly organized with excellent attention to detailCritical thinker with a solution-driven mindsetCapable of influencing cross-functional teams and stakeholdersExpertise:Knowledge of GMP, GTP, and cell therapy manufacturingFamiliarity with FDA/EU regulations including 21 CFR Parts 210, 211, 1271, and preferably 600–610Skilled in root cause analysis, CAPA, and risk managementExperience leading audits and functioning as an SME during inspectionsProficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)Experienced in resource planning, scheduling, and budget preparationComfortable with shift work, including weekends and unplanned overtimeWhat do we offer you?A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off. A supportive and innovative work environment. We value and encourage learning and personal development. The opportunity to work with people from all over the world. A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus. Many fun and informal events.About Legend BiotechLegend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.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.

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