Commercial Quality Lead - GDP, PV & Compliance

HAL Allergy Group; Leiden; On-site; EUR 90,000 - 130,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

GDP compliance

Quality oversight

Pharmacovigilance

QMS governance

Regulatory interface

Education

University degree in Pharmacy

Job description

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