Principal QA Specialist (Biotech)

Location: Onsite in Raheen, Limerick, Ireland

Salary: €63,200–€103,200 annually

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Serve as a Quality Systems subject matter expert with primary responsibility for Change Control governance and continuous improvement.
• Provide quality and compliance oversight for Change Controls, Deviations, CAPA, audits, customer complaints, and risk management.
• Review and approve Quality System documentation, including investigations, CAPA plans, risk assessments, and Change Control records.
• Lead or support governance forums, review boards, cross-functional meetings, and Quality System performance reviews.
• Monitor quality metrics and trends, identify process gaps and compliance risks, and implement sustainable corrective actions.
• Support regulatory inspections and customer audits while collaborating with Manufacturing, Quality Control, Engineering, MSAT, Supply Chain, Validation, and Regulatory Affairs.

Requirements

• BSc or BEng in a scientific discipline or related field.
• 7+ years of relevant experience in the pharmaceutical or related industry.
• Experience with Quality Systems, including Change Controls, Deviations, CAPA, Audit Management, or Risk Management.
• Working knowledge of cGMP requirements and regulatory expectations.
• Strong organizational, communication, and stakeholder management skills.
• Ability to work onsite in Raheen, Limerick, Ireland.

Culture & Benefits

• Science-driven environment focused on developing medicines for serious diseases.
• Opportunity to contribute to inspection readiness and operational excellence.
• Competitive total rewards package, which may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Inclusive workplace and reasonable accommodations during the recruitment process where required.