Qa validation & equipment compliance manager

Experteer OverviewIn this role, you provide quality oversight for qualification and validation activities, ensuring regulatory compliance and data integrity across GMP manufacturing. Se desidera saperne di più su questa opportunità o sta pensando di candidarsi, la preghiamo di leggere le seguenti informazioni. You will lead the site Validation Program and oversee CSV governance to guarantee products meet predefined quality standards throughout API and Finished Product operations. You will collaborate across functions to manage budgets, talent, and training, driving continuous improvement and risk-based validation strategies. This is a hands‐on leadership role within Global TechOp&S, focused on reliability, compliance, and operational excellence.Retribuzione / BenefitsProvide Quality oversight for qualification and validation activities in line with regulatory requirementsLead and manage the site Validation Program across equipment, processes, utilities, facilities, computerized systems, and laboratory instrumentsEnsure regulatory and GMP compliance for validation/qualification lifecycle management of manufacturing and lab equipmentGuarantee Data Integrity through proper CSV governance across site computerized systemsSupport budget definition and monitoring for departmental projectsContribute to workforce planning and competency development; set objectives aligned with MBO systemDefine and maintain organizational structure, roles, and responsibilities; promote training and developmentEnsure adherence to values, code of conduct, and applicable legal requirementsManage personnel in compliance with labor laws and safety regulations; plan and coordinate team activitiesResponsabilitàBachelor's or Master's Degree in a scientific or engineering discipline8–10 years of experience in pharmaceutical/biopharmaceutical manufacturing environmentsExtensive experience in validation and qualification of equipment and systems in cGMP environmentsStrong xivgfpx knowledge of EU and FDA regulatory requirements; experience with regulatory inspections (FDA/DEA)Proven track record in managing validated/qualified systemsAbility to define and execute multi-project strategiesStrong technical problem-solving and risk assessment skillsHigh initiative, accountability, and ability to work with minimal supervisionExcellent teamwork and interpersonal skillsRequisiti fondamentalicomprehensive healthcare programswork‐life balance initiativesrelocation supportcompetitive salary and performance bonusesflexible working arrangementsremote work options #J-18808-Ljbffr