Role Overview
We are seeking an experienced Responsible Person (RP) on a part-time contract basis to support our UK wholesale distribution operations. This role is critical in ensuring continued compliance with MHRA Good Distribution Practice (GDP) requirements and maintaining the integrity of our pharmaceutical supply chain, including the handling and distribution of controlled drugs (CDs).
The RP will be named on the Wholesale Distribution Authorisation (WDA) and will provide oversight of all GDP-related activities, ensuring that medicinal products—including controlled drugs—are stored, handled, and distributed in accordance with regulatory and legal requirements.
Key Responsibilities
- Act as the designated Responsible Person (RP) named on the WDA licence
- Ensure full compliance with UK GDP guidelines, Home Office requirements, and applicable regulatory standards
- Maintain oversight of all activities related to the procurement, storage, and distribution of medicinal products, including controlled drugs (Schedules 2–5 as applicable)
- Ensure that a Quality Management System (QMS) is implemented, maintained, and continuously improved
- Oversee and ensure compliance with controlled drug governance, including:
- Secure storage and access controls
- Accurate record keeping and registers
- Reconciliation and audit processes
- Investigation and reporting of discrepancies or losses
- Ensure appropriate licensing, authorisations, and procedures are in place for handling controlled drugs
- Approve and oversee suppliers and customers in line with GDP and controlled drug requirements
- Ensure appropriate qualification and training of personnel involved in GDP and controlled drug handling
- Manage and oversee deviations, CAPAs, change controls, and self-inspections
- Serve as the primary point of contact for MHRA inspections and, where applicable, Home Office inspections or inquiries
- Ensure appropriate handling of complaints, returns, suspected falsified medicines, and recalls, including those involving controlled drugs
- Maintain oversight of temperature-controlled storage and distribution activities
- Provide ongoing guidance to operational teams to ensure compliance is embedded in day-to-day activities
Qualifications & Experience
- Must meet MHRA eligibility requirements to act as a Responsible Person (RP)
- Previously named on a Wholesale Distribution Authorisation (WDA) as an RP (required)
- Strong working knowledge of EU/UK GDP guidelines
- Demonstrated experience supporting or leading MHRA inspections
- Proven experience managing or overseeing controlled drugs within a wholesale or regulated environment
- Familiarity with UK Misuse of Drugs Regulations and Home Office expectations
- Ability to operate independently in a contract/advisory capacity while maintaining accountability
Mandatory Requirements
- Enhanced DBS check (current or willingness to obtain prior to start)
- Previously named on CD registration
- Eligible to be named on a UK WDA licence
- Right to work in the United Kingdom
Key Competencies
- Strong regulatory judgment and decision-making capability
- Ability to balance compliance with operational practicality
- Clear, direct communication style with both regulators and internal stakeholders
- High level of integrity and accountability
- Detail-oriented with a pragmatic approach to risk
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