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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Experience with allergen immunotherapy…