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