Ph3Experteer Overview /h3pIn 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 TechOpS, focused on reliability, compliance, and operational excellence. /ph3Retribuzione / Benefits /h3ulliProvide Quality oversight for qualification and validation activities in line with regulatory requirements /liliLead and manage the site Validation Program across equipment, processes, utilities, facilities, computerized systems, and laboratory instruments /liliEnsure regulatory and GMP compliance for validation/qualification lifecycle management of manufacturing and lab equipment /liliGuarantee Data Integrity through proper CSV governance across site computerized systems /liliSupport budget definition and monitoring for departmental projects /liliContribute to workforce planning and competency development; set objectives aligned with MBO system /liliDefine and maintain organizational structure, roles, and responsibilities; promote training and development /liliEnsure adherence to values, code of conduct, and applicable legal requirements /liliManage personnel in compliance with labor laws and safety regulations; plan and coordinate team activities /li /ulh3Responsabilità /h3ulliBachelor’s or Master’s Degree in a scientific or engineering discipline /lili8–10 years of experience in pharmaceutical/biopharmaceutical manufacturing environments /liliExtensive experience in validation and qualification of equipment and systems in cGMP environments /liliStrong knowledge of EU and FDA regulatory requirements; experience with regulatory inspections (FDA/DEA) /liliProven track record in managing validated/qualified systems /liliAbility to define and execute multi-project strategies /liliStrong technical problem-solving and risk assessment skills /liliHigh initiative, accountability, and ability to work with minimal supervision /liliExcellent teamwork and interpersonal skills /li /ulh3Requisiti fondamentali /h3ullicomprehensive healthcare programs /liliwork‑life balance initiatives /lilirelocation support /lilicompetitive salary and performance bonuses /liliflexible working arrangements /liliremote work options /li /ul /p #J-18808-Ljbffr