Responsible Person

Walker Cole International is partnering with a global pharmaceutical organisation to appoint a Responsible Person (RP) to take ownership of GDP compliance and Quality oversight across their wholesale distribution activities in Ireland and Europe. This is a key leadership position, working closely with senior management to ensure full regulatory compliance and the safe distribution of medicinal products across multiple markets.

As a Responsible Person, you will be responsible for:

• Ensuring the Quality Management System (QMS) is implemented, maintained, and continuously improved in line with EU GDP guidelines and applicable regulations.
• Maintaining oversight of all wholesale distribution activities, including supplier/customer approval, audits, and ensuring inspection readiness.
• Leading and managing deviations, CAPAs, change controls, complaints, and recall activities to ensure compliance and patient safety.
• Acting as the named RP on the Wholesale Distribution Authorisation (WDA), ensuring licence obligations are met and providing regulatory guidance to senior stakeholders.

To be successful as a Responsible Person, you will have:

• Eligibility to act as a named Responsible Person under EU GDP requirements.
• A degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline.
• Experience within a GDP-regulated pharmaceutical distribution environment, including oversight responsibilities.
• Strong knowledge of EU GDP regulations, with experience operating within a Quality Management System and managing audits/inspections.

Responsible Person | RP | GDP | Wholesale Distribution | WDA | Quality Assurance | QMS | Pharmaceutical Distribution | Compliance | Audits | CAPA | Deviations | Supplier Qualification | Regulatory Inspections | EU GDP | Supply Chain