Technical Director – Warehousing (Distributor-Based)

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.

**About the Role:**

We are looking for a
**Technical Director for Albania & Responsible Person for QMS for Albania and Kosovo warehouses.**
This role will be based at our distributor Trimed’s office and will require approximately 20% travel to Kosovo.

**Responsibilities:**

- Responsible for overseeing wholesale activities in Albania and overseeing GDP compliance, establishing, implementing, and maintaining the Quality Management System (QMS) for Dompé’s pharmaceutical distribution warehouses in Albania and Kosovo.
- Ensures 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.

**Long Description: As Technical Director (Albania):**

- Ensures that import and export of drugs is performed in accordance with local applicable requirements and that all necessary authorizations by relevant Regulatory Authorities are obtained.
- Ensures that distribution of medicinal products in Albania and Kosovo is only made after Authorization of Use is issued by the competent authorities and after the labelling according to the local applicable legislation is executed.
- Ensures that wholesale drug transactions are carried out with the required invoice and accompanying documentation, and only in his/her presence, unless a delegated pharmacist assumes these responsibilities during his/her absence.
- Ensures that no retail sale of drugs is made from wholesale distributor.
- Ensure regulatory compliance of the activities conducted towards local products registration.
- Leads and manages all technical and quality related aspects of warehouse operations (pharmaceutical products import, storage, labelling, sale & distribution) ensuring regulatory compliance and accuracy of recorded data.
- Ensures that all the reworking (e.g. labeling) activities conducted in the Dompé warehouse occur only under GMP authorization and are conducted in compliance with GMP requirements and prevent contamination, mix-ups, theft, or counterfeiting.
- Oversees supplier qualification, local label verification and approval of labelling (with drug control stamp or product information label in local language) batch record documentation and conformity statement.

**As Responsible person for QMS (Albania & Kosovo):**

- Ensures that all the wholesale activities – storage and distribution – comply with national pharmaceutical legislation and EU Good Distribution Practice (GDP).
- Supervises the implementation of the QMS and ensures its compliance with local legislation and internal procedures.
- Ensures the implementation of a documented Quality Risk Management (QRM) process within the Quality Management System (QMS), including risk identification, assessment, control, and review for all GDP-related activities.
- Conducts periodic Management Reviews of the QMS to evaluate its effectiveness, compliance with regulatory requirements, and opportunities for continuous improvement.
- Ensures that all personnel—including contractors and consultants, where applicable—are adequately trained and competent to perform their assigned roles.
- Manages recalls, deviations, complaints, CAPA according to relevant requirements.
- Ensures execution of internal audits at defined intervals with effective CAPA.
- Ensures that all changes are managed according to relevant requirements.
- Decides on the fate of returned/rejected/withdrawn/falsified products and approves reintroduction into saleable stock according to local legislation and internal procedures.
- Ensures availability of periodic thermal mapping, continuous monitoring, excursion management, and qualification of storage/transport areas.
- Ensures compliance towards local legislation on labeling and drug stamp, where applicable.
- Oversees supplier qualification.
- Maintains documentation and exercises independent authority in quality matters.
- Holds records on all delegated duties.
- Serves as primary contact for regulatory inspections.
- Exercises full authority and independence in all areas of responsibility.
- Acts as point of contact with the vendor that supplies operational and quality services.

**Education:**

- Pharmacy degree (5-year university cycle or equivalent recognized by Albanian and Kosovan authorities).
- Registered member of the Albanian Order of Pharmacists.
- At least two years of experience in pharmaceutical service.

**Technical Expertise:**

- Languages: Albanian and English (fluent), also knowledge of Italian is preferred.
- Knowledge of MS Office.
- At least 2 years of proven professional experience in pharmaceutical services (Quality function of national and/or international pharmaceutical companies is preferred) required.