Lead Commercial Quality Manager

• Ensure GDP oversight and adherence within the operating model for Leiden, supporting local setup and governance in line with EU and national regulations.
• Establish and maintain the Quality Management System (QMS) for commercial distribution activities.
• Approve GDP-relevant SOPs and ensure compliance training for commercial teams.
• Monitor GDP KPIs and quality metrics for the Quality Management Review Affiliates.
• Oversee qualification and performance monitoring of logistics and distribution partners.
• Manage customer qualification processes and exercise authority to block non-compliant customers.
• Provide oversight of order intake, release, and shipment processes to ensure compliance.
• Ensure GDP-compliant transport and manage temperature-sensitive product logistics.
• Handle returns and complaints, supporting local recall execution as necessary.
• Ensure local pharmacovigilance activities are performed and collaborate with regulatory teams.
• Serve as the primary contact for Spanish and Italian competent authorities and support interactions with local authorities.

• 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 working closely with a Responsible Person / Director Técnico and commercial PV functions.

• 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.

Join HAL Allergy and be part of an innovative pharmaceutical manufacturer. We offer a culturally diverse environment with opportunities for personal growth and development, located just a short bike ride from the center of Leiden.