Experteer Overview Potrebbe essere proprio lei il candidato/la candidata ideale per questo lavoro. Legga tutte le informazioni associate e invii la sua candidatura. In this role, you provide quality oversight for qualification and validation activities, ensuring regulatory compliance and data integrity across GMP manufacturing. 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 / Benefits Provide Quality oversight for qualification and validation activities in line with regulatory requirements Lead and manage the site Validation Program across equipment, processes, utilities, facilities, computerized systems, and laboratory instruments Ensure regulatory and GMP compliance for validation/qualification lifecycle management of manufacturing and lab equipment Guarantee Data Integrity through proper CSV governance across site computerized systems Support budget definition and monitoring for departmental projects Contribute to workforce planning and competency development; set objectives aligned with MBO system Define and maintain organizational structure, roles, and responsibilities; promote training and development Ensure adherence to values, code of conduct, and applicable legal requirements Manage personnel in compliance with labor laws and safety regulations; plan and coordinate team activities Responsabilità Bachelor's or Master's Degree in a scientific or engineering discipline 8–10 years of experience in pharmaceutical/biopharmaceutical manufacturing environments Extensive experience in validation and qualification of equipment and systems in cGMP environments Strong knowledge of xrdztoy EU and FDA regulatory requirements; experience with regulatory inspections (FDA/DEA) Proven track record in managing validated/qualified systems Ability to define and execute multi-project strategies Strong technical problem-solving and risk assessment skills High initiative, accountability, and ability to work with minimal supervision Excellent teamwork and interpersonal skills Requisiti fondamentali comprehensive healthcare programs work‐life balance initiatives relocation support competitive salary and performance bonuses flexible working arrangements remote work options #J-18808-Ljbffr