Responsible Person – Netherlands

BioTalent is partnered with a leading global pharmaceutical company to support the hire of a Responsible Person, with expertise in EU GDP compliance, quality management, and wholesale distribution.

This role will offer you:

• Acting as the designated Responsible Person and providing support on a global scale.
• Leading compliance and quality across storage, transport, and distribution activities.
• Driving continuous improvement of the GDP Quality Management System.

Key Responsibilities:

• Ensure compliance with EU GDP legislation, directives, and Dutch Medicines/Opium Acts, including audits, traceability, and supplier approvals.
• Maintain and oversee the GDP Quality Management System (SOPs, training, CAPAs, and QMS metrics).
• Support product recalls, customer complaints, and collaborate with QPs and regulatory authorities.
• Manage outsourced activities, quality contracts, and risk-based supply chain oversight.

Key Requirements:

• Bachelor’s degree (MSc preferred).
• 5+ years in pharmaceutical quality management.
• Eligible and trained as a Responsible Person under EU GDP.
• Experience in GDP auditing, QA for controlled products, and managing compliance.