Technical Director

Dompé is a biopharmaceutical company driven by innovation and research, with headquarters in Milan and operations across Europe and the United States. We focus on developing and delivering therapeutic solutions in areas of high unmet medical need, combining scientific excellence, digital innovation, and a strong commitment to improving patients’ lives.Role: Technical Director – Tirana As Technical Director, you will oversee wholesale activities and GDP compliance, establishing, implementing, and maintaining the Quality Management System (QMS) for Dompé’s pharmaceutical distribution warehouses in Albania and Kosovo. You will ensure regulatory compliance and full adherence to national regulations and applicable legislation for all technical and professional activities related to the wholesale distribution of medicinal products and food supplements.Key Responsibilities:Wholesale Activities & Regulatory ComplianceEnsure import and export of drugs are performed according to local requirements and obtain necessary authorizations.Oversee distribution of medicinal products in Albania and Kosovo only after Authorization of Use and compliant labeling.Ensure wholesale drug transactions are executed with required documentation and in your presence, unless delegated.Prevent any retail sale of drugs from the wholesale distributor.Quality Management System (QMS)Ensure all wholesale activities comply with national pharmaceutical legislation and EU Good Distribution Practice (GDP).Supervise the QMS implementation and ensure compliance with local legislation and internal procedures.Implement a documented Quality Risk Management (QRM) process covering all GDP-related activities.Conduct periodic Management Reviews to evaluate QMS effectiveness and opportunities for improvement.Ensure personnel and contractors are adequately trained and competent.Manage recalls, deviations, complaints, CAPA, and internal audits with effective follow-up.Approve the fate of returned/rejected/withdrawn/falsified products per local legislation and internal procedures.Lead all technical and quality aspects of warehouse operations including import, storage, labelling, sale & distribution.Maintain thermal mapping, monitoring, excursion management, and qualification of storage/transport areas.Ensure labeling, reworking, and GMP-compliant operations in warehouse activities.Oversee supplier qualification, local label verification, and approval of labeling and batch records.Serve as primary contact for regulatory inspections and liaise with competent authorities when required.Forward adverse events to Pharmacovigilance Department per regulatory requirements.Exercise full authority and independence in all areas of responsibility.Education & Experience:Pharmacy degree (5-year university cycle or equivalent recognized by Albanian and Kosovan authorities).Registered member of the Albanian Order of Pharmacists.Minimum 2 years of experience in pharmaceutical service.Technical Expertise:Languages: Fluent in Albanian and English; Italian is a plus.Knowledge of MS Office.At least 2 years of proven professional experience in pharmaceutical services; experience in the Quality function of national and/or international pharmaceutical companies is preferred.Local Applicable Legislation:Law No.105/2014 on drugs and the pharmaceutical service, as amended (Albania)Ministerial Order No. 660/2018 (Albania)Law No. 04/L-190 (Kosovo)Administrative Instruction No. 13/2013 (Kosovo)