Jobid: 641709744325329428 (0.0503)
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 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).
Supplier, subcontractors & Customer Qualification
Oversee qualification and ongoing performance monitoring of:
Logistics, transport providers and other subcontractors involved in GDP activitiesDistribution 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
You have
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
Lees hier meer…
Deel deze vacature:
