Senior Quality Specialist – Pharmaceutical

About the role

We are seeking a Senior Quality Specialist to join a leading pharmaceutical company in County Offaly. The role focuses on ensuring the Quality Management System meets all regulatory requirements and supports safe distribution of medicinal products.

Key responsibilities

• Assist in the development, implementation and maintenance of the Quality Management System.
• Ensure compliance with Good Distribution Practice (GDP) and HPRA guidelines (IA‑G0046) across all distribution activities.
• Provide training and communication to embed quality processes throughout the business.
• Verify that only authorised product classes are procured from approved suppliers and supplied to approved customers under the Wholesale Distribution Authorisation.
• Support approval of outsourced service providers and qualification of transport providers.
• Review, draft and approve documentation such as change controls, deviations, validation records and SOPs.
• Conduct initial and ongoing bona‑fide checks on suppliers and customers.
• Maintain a company‑wide risk‑management culture and update Quality Technical Agreements.
• Manage product returns, ensuring they are secured and only released after RP approval.
• Assess temperature‑controlled shipments and make quality decisions.

Required profile

• Minimum 5 years of QA experience in an EU‑regulated environment.
• Strong understanding of pharmaceutical wholesale distribution models and regulatory requirements.
• Excellent interpersonal skills and ability to work in a matrix organisation.
• Effective written and verbal communication, with the ability to present to varied audiences.

Required skills

• Quality Management System (QMS) implementation.
• Good Distribution Practice (GDP) knowledge.
• Health Products Regulatory Authority (HPRA) guidelines.
• Temperature‑controlled activity expertise.