Commercial Quality Lead: GDP & PV Oversight

HAL Allergy International; Leiden; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy International in Leiden seeks an experienced professional to lead GDP and quality oversight for commercial distribution of prescription medicines across EU markets. The role interfaces with Commercial, Quality, Supply Chain, Regulatory and Pharmacovigilance functions to ensure compliant operations and continuous improvement.

The position requires a Pharmacy degree, proven GDP/commercial PV experience and the ability to collaborate with EU authorities.

Qualifications

• University degree in Pharmacy or closely related discipline.
• Proven GDP-compliant distribution of prescription medicines.
• Strong knowledge of EU GDP and pharmacovigilance.
• Experience as Responsible Person/Director Técnico and commercial PV functions.

Responsibilities

• Oversee GDP compliance for Leiden operations and partner sites.
• Maintain and continuously improve the Quality Management System (QMS) for commercial distribution.
• Approve GDP-relevant SOPs and support recalls as instructed by MAH.
• Ensure GDP training and awareness for commercial teams at affiliate sites.
• Monitor GDP KPIs/quality metrics and oversee subcontractor qualification and performance.

Skills

GDP compliance

Quality oversight

Regulatory liaison

PV awareness

Pharma distribution

Education

Pharmacy degree

Job description

HAL Allergy International in Leiden seeks an experienced professional to lead GDP and quality oversight for commercial distribution of prescription medicines across EU markets. The role interfaces with Commercial, Quality, Supply Chain, Regulatory and Pharmacovigilance functions to ensure compliant operations and continuous improvement.

The position requires a Pharmacy degree, proven GDP/commercial PV experience and the ability to collaborate with EU authorities.