Key Skills

Job Description

The Lead Commercial Quality ensures that commercial distribution activities are conducted in full compliance with EU Good Distribution Practice (GDP) and EU Good Pharmacovigilance Practice (GVP), while supporting business growth through pragmatic, risk-based governance. The position enables the compliant supply of prescription products, particularly allergen immunotherapy (AIT), exclusively to authorized pharmacies and serves as a key interface between Commercial, Quality, Supply Chain, Regulatory, and Pharmacovigilance functions. The role reports functionally to the Head of Quality (Leiden). Primary work location: Leiden | Scope: Spain, Italy, Germany, Austria Responsibilities Good Distribution Practice (GDP) & Quality Oversight Ensure GDP oversight and adherence to GDP within operating model for Leiden, supporting local setup and governance in line with EU and national regulations Establish, maintain, and continuously improve the Quality Management System (QMS) applicable to commercial distribution activities Approve GDP-relevant SOPs, including Order-to-Cash, transport, deviations, returns, and support local execution of recalls as instructed by the MAH Ensure GDP-compliant training, qualification, and ongoing awareness of commercial teams at affiliate sites Monitoring/trending of GDP KPIs/quality metrics for the QMRA (Quality Management Review Affiliates). Supplier, subcontractors & Customer Qualification Oversee qualification and ongoing performance monitoring of: Logistics, transport providers and other subcontractors involved in GDP activities Distribution and commercial partners Ensure robust customer qualification processes, supplying prescription products exclusively to authorized pharmacies Exercise authority to block customers, suspend shipments or stop distribution activities in case of GDP or regulatory non-compliance Distribution Control Provide GDP oversight of order intake, release, and shipment processes Ensure no shipment occurs without qualified customers, approved products and compliant distribution and transport conditions Review, approve and govern deviations, exceptions, and manual overrides within commercial operations Transport, Cold Chain & Supply Chain Interfaces Ensure GDP-compliant transport, including cold-chain management for temperature-sensitive products Manage temperature monitoring, excursions, investigations, and CAPAs Act as key interface to Supply Chain Management and external logistics providers Returns, Complaints & Recalls Handle returns and distribution-related complaints within commercial operations Support local execution of recalls based on decision and instruction of MAH Ensure recall readiness, including execution of mock recall activities Pharmacovigilance (PV) Oversight Ensure local commercial pharmacovigilance activities are performed, such as timely identification, documentation and escalation of safety information arising from commercial activities and oversee PV training and awareness for commercial staff and partners at affiliate sites Collaborate closely with the EU QPPV, Local Drug Safety Officers (LDSO) and Regulatory teams Support compliance with EU and national pharmacovigilance requirements Regulatory & Authority Interface Serve as the primary contact for Spanish and Italian competent authorities (AEMPS and regional authorities) Support and coordinate interactions with Italian authorities (AIFA) in collaboration with local and group functions Profile Mandatory University degree in Pharmacy or a closely related scientific discipline Proven experience in GDP-compliant commercial distribution of prescription medicines Strong knowledge of EU GDP and pharmacovigilance frameworks Experience acting as, or working closely with, a Responsible Person / Director Técnico and commercial PV functions Preferred Experience with allergen immunotherapy AIT, biologics, or temperature-sensitive products Experience across multiple EU markets, ideally Spain and Italy Direct experience supporting or leading EU authority inspections Fluency in English and Spanish. Italian is a strong asset HAL Allergy, for those who seek pharmaceutical innovation HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity! HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.

Core Responsibilities

Lead GDP and quality oversight for commercial distribution, maintaining the applicable QMS and ensuring compliant customer qualification, order release, transport, returns, complaints, and recalls. Oversee local commercial pharmacovigilance activities and coordinate with supply chain, regulatory, quality, and competent authorities across Spain, Italy, Germany, and Austria.

Requirements

Requires a university degree in Pharmacy or a closely related scientific discipline, proven experience in GDP-compliant distribution of prescription medicines, and strong knowledge of EU GDP and pharmacovigilance frameworks. Candidates should have experience as or alongside a Responsible Person / Director Técnico and commercial PV functions, plus fluency in English and Spanish; Italian is an asset.