Lead Commercial Quality (m/f/d) in Leiden

TheLead Commercial Qualityensures 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

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).

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

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

Who are we looking for?
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Our offer

You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.

A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient's well-being is always our top priority. This combination is the basis for an interesting and challenging environment.

You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.

Being part of a company that is geared towards helping people live happier and healthier lives.

A competitive salary that matches your responsibilities and experience.

30 leave days.

Company contribution to a pension package and health insurance.

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.