QA Manager/ RP

Walker Cole International is searching for a Quality Assurance Manager, GDP / Responsible Person (RP) to join a growing pharmaceutical organisation as they establish and expand their Irish operations. This is a key quality leadership role, combining named RP responsibilities with oversight of GDP quality systems and third-party distribution activities.

The candidate should be based in Ireland, but the role can be done remotely.

You will be responsible for:

• Acting as the named Responsible Person (RP) on a Wholesale Distribution Authorisation, ensuring compliance with EU GDP (2013/C 343/01) and HPRA requirements.
• Managing and maintaining the GDP Quality Management System (QMS), including deviations, CAPAs, change control, risk management and quality metrics.
• Leading inspection readiness activities and supporting regulatory inspections, audits and recall simulations.
• Providing quality oversight of third-party storage, distribution and supply chain partners, including quality agreements and supplier qualification.

The successful candidate will have:

• A degree or equivalent qualification in a scientific or related discipline.
• Eligibility to act as a Responsible Person under EU GDP requirements in Ireland.
• Proven experience in a GDP-regulated pharmaceutical environment, with hands-on responsibility for QMS, audits and third-party oversight.
• Strong working knowledge of EU GDP and HPRA guidance, with a pragmatic, risk-based approach to quality and stakeholder management.

Quality Assurance Manager | Quality Manager | Responsible Person | RP | GDP | Good Distribution Practice | EU GDP | HPRA | Pharmaceutical | QA | QMS | CAPA | Change Control | Supplier Management | Distribution | Supply Chain | Regulatory | Dublin | Hybrid | Remote