Lead Commercial Quality (m/f/d)
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
Your tasks
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 regulationsEstablish, maintain, and continuously improve the Quality Management System (QMS) applicable to commercial distribution activitiesApprove GDP-relevant SOPs, including Order-to-Cash, transport, deviations, returns, and support local execution of recalls as instructed by the MAHEnsure GDP-compliant training, qualification, and ongoing awareness of commercial teams at affiliate sitesMonitoring/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 activitiesDistribution and commercial partnersEnsure robust customer qualification processes, supplying prescription products exclusively to authorized pharmaciesExercise authority to block customers, suspend shipments or stop distribution activities in case of GDP or regulatory non-complianceDistribution Control
Provide GDP oversight of order intake, release, and shipment processesEnsure no shipment occurs without qualified customers, approved products and compliant distribution and transport conditionsReview, approve and govern deviations, exceptions, and manual overrides within commercial operationsTransport, Cold Chain & Supply Chain Interfaces
Ensure GDP-compliant transport, including cold-chain management for temperature-sensitive productsManage temperature monitoring, excursions, investigations, and CAPAsAct as key interface to Supply Chain Management and external logistics providersReturns, Complaints & Recalls
Handle returns and distribution-related complaints within commercial operationsSupport local execution of recalls based on decision and instruction of MAHEnsure recall readiness, including execution of mock recall activitiesPharmacovigilance (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 sitesCollaborate closely with the EU QPPV, Local Drug Safety Officers (LDSO) and Regulatory teamsSupport compliance with EU and national pharmacovigilance requirementsRegulatory & 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 functionsYou have
Mandatory
University degree in Pharmacy or a closely related scientific disciplineProven experience in GDP-compliant commercial distribution of prescription medicinesStrong knowledge of EU GDP and pharmacovigilance frameworksExperience acting as, or working closely with, a Responsible Person / Director Técnico and commercial PV functionsPreferred
Experience with allergen immunotherapy AIT, biologics, or temperature-sensitive productsExperience across multiple EU markets, ideally Spain and ItalyDirect experience supporting or leading EU authority inspectionsFluency in English and Spanish. Italian is a strong asset