About this role
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 documentationHold 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 license2. Training and Competency Management
Implement and maintain GDP training programs for all personnel involved in medicinal product distributionEnsure employees receive appropriate GDP training and remain up to date with regulatory requirementsInform and train team members on changes in GDP regulations and quality systems3. GDP Operational Oversight
The RP has full responsibility for:
Authorizing all quality-related activities and recordsCoordinating product recalls or supporting recalls initiated by the Marketing Authorization Holder (MAH)Managing distribution-related deviationsManaging customer complaintsBeing available 24/7 for transport-related complaints and deviationsApproving suppliers, customers, and outsourced/subcontracted activities related to distributionManaging the self-inspection program to verify GDP compliance and implementation of CAPAsAuthorizing the handling of returned, rejected, recalled, and falsified medicinal products, including decisions on returning products to saleable stockReporting potential medicinal product shortages to the Dutch national portalEnsuring implementation of any additional legal requirements applicable to specific products4. Falsified Medicines Directive (FMD) Responsibilities
Support implementation of Falsified Medicines Directive requirementsEnsure robust procedures are in place to identify and manage actual or potential falsified medicines within the supply chainEnsure compliance with applicable FMD requirements5. Delegation and Deputy Management
Maintain records of all delegated responsibilitiesDocument what was delegated, to whom, and the duration of delegation where applicableSummary of RP Accountabilities
The RP is accountable for:
GDP compliance and maintenance of the distribution licenceQMS oversightTraining and competency managementDeviations, complaints, recalls, and CAPA managementSupplier, customer, and contractor qualification/approvalManagement of returned, recalled, rejected, and falsified productsShortage reportingFMD complianceDocumentation 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