Qualified Person and Responsible Person - UK

Overview

In this role you will oversee GDP-compliant distribution activities in Europe from the Cambridge, UK office, reporting to the Head of Quality - UK. You will lead the GDP Quality Management System, training, and 24/7 operational oversight to safeguard product integrity across import, storage, and transport. Working closely with MAH, suppliers, and regulatory bodies, you’ll drive continuous improvement and ensure license maintenance. This is a hands-on position at the intersection of quality, compliance, and distribution in a global pharma setting.

Responsibilities

• Implement and maintain the GDP Quality Management System and related documentation
• Hold ultimate responsibility for products manufactured in Europe and stored/transported under the Wholesale Distribution Authorization
• Ensure compliance necessary to obtain and maintain the distribution license
• Implement and maintain GDP training programs for all personnel involved in medicinal product distribution
• Inform and train team members on changes in GDP regulations and quality systems
• Authorizing all quality-related activities and records
• Coordinating product recalls or supporting recalls initiated by MAH
• Managing distribution-related deviations
• Managing customer complaints
• Being available 24/7 for transport-related complaints and deviations
• Approving suppliers, customers, and outsourced/subcontracted activities related to distribution
• Managing the self-inspection program to verify GDP compliance and CAPA implementation
• Authorizing handling of returned, rejected, recalled, and falsified medicinal products
• Reporting potential medicinal product shortages to the Dutch national portal
• Ensuring implementation of additional legal requirements for specific products
• Support implementation of FMD requirements

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 pharmaceutical industry
• Analytical decision making
• Stakeholder management
• Excellent communication skills
• GMP/GDP expertise
• Regulatory compliance knowledge
• Quality management systems (QMS)

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