
Provides Quality oversight and formal approval for qualification and validation activities in compliance with regulatory requirements. Leads and controls the site Validation Program, covering equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments. Ensures regulatory and GMP compliance in the management of validation and qualification processes. Guarantees Data Integrity compliance across all site computerized systems. Supports the Quality Management in defining, allocating, and monitoring the budget related to departmental projects and initiatives. Contributes to workforce planning by assessing required FTEs and identifying necessary competencies. Defines and maintains the internal organizational structure, including roles, responsibilities, and job assignments. Sets and assigns qualitative and performance objectives in alignment with the company's MBO system. Promotes team development through tailored training plans and coaching programs based on individual needs. Ensures that managed personnel remain aligned with corporate competency frameworks and organizational behaviors. Manages personnel in compliance with labor laws, contractual obligations, and workplace health and safety regulations. Ensures operational efficiency and safety of departments, facilities, and equipment. Proposes necessary investments to maintain safety, compliance, and operational effectiveness. Ensures fulfillment of mandatory information, training, and employee instruction obligations in accordance with applicable health and safety regulations. Collaborates