QA Compliance Specialist

About the role

AbbVie is seeking a QA Compliance Specialist to join its Ballytivnan site. Reporting to the Quality Systems Manager, you will help build and maintain a robust quality system that meets all regulatory and AbbVie requirements.

Key responsibilities

• Coordinate the quality system and ensure full compliance across all personnel.
• Manage Product Quality Reviews, Technical Agreements, Track‑and‑Trend activities, and site‑wide QRM initiatives.
• Facilitate RCS and FMEA activities, conduct internal audits, and support change management processes.
• Investigate customer complaints, implement corrective and preventive actions (CAPA), and verify their effectiveness.
• Liaise with Global Quality Assurance, FDA, HPRA and other regulatory bodies.
• Oversee the supplier program, perform vendor audits, and maintain commodity specifications.
• Support inspection readiness, including preparation, logistics, and documentation management.

Required profile

• Third‑level qualification in a science, quality or engineering discipline.
• Minimum 3 years of experience in a similar QA/compliance role within the pharmaceutical industry.

Required skills

• Quality Management System (QMS) coordination
• CAPA implementation and verification
• Regulatory compliance (FDA, HPRA)
• Internal audit execution
• Change management and control
• Supplier and vendor audit management