Lead Commercial Quality (m/f/d)

HAL Allergy Group; Leiden; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

HAL Allergy leads quality governance for commercial distribution of prescription medicines from Leiden. The Lead Commercial Quality ensures GDP and GVP compliance, supporting business growth through risk-based governance and cross-functional collaboration with Commercial, Quality, Supply Chain, Regulatory and PV teams.

The role focuses on establishing a robust QMS, GDP oversight, training, and KPI monitoring across affiliate sites, with responsibility for recalls, deviations, and supplier

Qualifikationen

• 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.

Aufgaben

• Provide GDP oversight of order intake, release, and shipment processes.
• Approve GDP-relevant SOPs and support local execution of recalls as instructed by MAH.
• Ensure GDP-compliant training, qualification, and ongoing awareness of commercial teams at affiliate sites.
• Monitor/trend GDP KPIs and QMRA metrics; oversee subcontractors and distributors.

Kenntnisse

GDP compliance

Quality oversight

Pharmacovigilance

QMS governance

Regulatory interface

Ausbildung

University degree in Pharmacy

Jobbeschreibung

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).
• 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.