HAL Allergy is hiring a

Lead Commercial Quality South

Leiden, Netherlands

General information

Primary work location: Spain | Scope: Spain & Italy

The Lead Commercial Quality South 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 in the Southern European markets.

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.

Your tasks

Good Distribution Practice (GDP) & Quality Oversight

Act as the non-statutory GDP Responsible Person / Director Técnico for the Spanish commercial organization, in line with local regulatory requirements
Ensure GDP oversight and adherence to GDP within operating model for Italy, 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 in Spain and Italy
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 in Spain and Italy
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 competent authorities (AEMPS and regional authorities)
Support and coordinate interactions with Italian authorities (AIFA) in collaboration with local and group functions

Your skills

Mandatory

University degree in Pharmacy 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

Our offer

A senior cross‑market role with real authority and professional impact.
Opportunity to shape GDP and PV systems across Spain and Italy.
Competitive compensation and benefits package.
A collaborative, international, quality‑driven culture

Who are we looking for?

This is a senior, high‑impact role at the intersection of regulatory compliance, product quality, and patient safety. You will be the key point of authority for GDP and the principal local pharmacovigilance contact, ensuring our operations remain fully compliant with EU and national regulations.

Your application

We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.

Important notice for search firms and recruitment agencies

HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HAL Allergy.

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 HAL 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 part of an innovative and challenging pharmaceutical manufacturer, then this is a 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.

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Lead Commercial Quality South

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