Qualified Person and Responsible Person – UK

Overview

In this role you will oversee GDP-compliant distribution of medicinal products and maintain the UK quality framework. You will work tightly with the UK office and Head of Quality to ensure regulatory alignment, safety, and issue resolution across import, storage, transport, and distribution. You’ll drive the QMS, training, and CAPA programs while supporting FMD and regulatory obligations. This is a hands-on, regulatory-focused role with a strong impact on patient access and product integrity.

Responsibilities

• Maintain and implement the GDP Quality Management System and related docs
• Hold ultimate responsibility for products manufactured in Europe and stored/transported under the Wholesale Distribution Authorization
• Ensure compliance to obtain and maintain the distribution license
• Implement GDP training programs for distribution personnel and keep them updated
• Coordinate product recalls and support MAH-initiated recalls
• Manage distribution-related deviations, complaints, and 24/7 transport-related issues
• Approve suppliers, customers, and outsourced activities
• Oversee self-inspection program and CAPA implementation
• Authorize handling of returned/rejected/recalled/falsified products
• Report shortages to the Dutch national portal
• Ensure compliance with FMD and related legal requirements
• Document delegation records and durations
• SupportFMD implementation and robust falsified medicine controls

Key requirements

• Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field
• Eligible to act as a Qualified Person under UK/EU regulations
• Significant Quality Assurance experience in pharma industry

• Stakeholder management
• Excellent communication skills
• Analytical decision making
• GMP/GDP expertise
• Auditing and compliance knowledge
• CAPA and deviation management

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