Qualified Person and Responsible Person - UK

We are seeking a Responsible Person (RP) in our Quality Assurance team, to be based in person from our Cambridge, UK office and report to Head of Quality - UK. You will be accountable for ensuring that all activities related to the importation, storage, transportation, and distribution of medicinal products are conducted in compliance with applicable UK Good Distribution Practice (GDP) requirements, the Human Medicines Regulations 2012 (as amended), and other relevant regulatory obligations.

Responsibilities:

Quality Management System (QMS)

• Implement and maintain the GDP Quality Management System and related documentation
• Hold ultimate responsibility for products manufactured in Europe and stored/transported under the WDA (Wholesale Distribution Authorization)
• Ensure compliance necessary to obtain and maintain the distribution license

2. Training and Competency Management

• Implement and maintain GDP training programs for all personnel involved in medicinal product distribution
• Ensure employees receive appropriate GDP training and remain up to date with regulatory requirements
• Inform and train team members on changes in GDP regulations and quality systems

3. GDP Operational Oversight

The RP has full responsibility for:

• Authorizing all quality-related activities and records
• Coordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (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 implementation of CAPAs
• Authorizing the handling of returned, rejected, recalled, and falsified medicinal products, including decisions on returning products to saleable stock
• Reporting potential medicinal product shortages to the Dutch national portal
• Ensuring implementation of any additional legal requirements applicable to specific products

4. Falsified Medicines Directive (FMD) Responsibilities

• Support implementation of Falsified Medicines Directive requirements
• Ensure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chain
• Ensure compliance with applicable FMD requirements

5. Delegation and Deputy Management

• Maintain records of all delegated responsibilities
• Document what was delegated, to whom, and the duration of delegation where applicable

Summary of RP Accountabilities

The RP is accountable for:

• GDP compliance and maintenance of the distribution licence
• QMS oversight
• Training and competency management
• Deviations, complaints, recalls, and CAPA management
• Supplier, customer, and contractor qualification/approval
• Management of returned, recalled, rejected, and falsified products
• Shortage reporting
• FMD compliance
• Documentation of delegated responsibilities

Education & Experience:

• Master Degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences or related field

• Eligible to act as a Qualified Person under applicable UK/EU regulations

• Significant Quality Assurance experience in pharmaceutical industry

Key Skills & Competencies:

• GMP/GDP expertise

• Strong auditing and compliance knowledge

• Analytical decision making

• Stakeholder management

• Excellent communication skills