Senior QA Specialist (Pharmaceutical Manufacturing)

Location: Raheen, Limerick, Ireland; onsite

Salary: €54,200–€88,400 annually

Company

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

What you will do

• Lead and support quality assurance activities for technology transfer projects.
• Provide QA oversight for new manufacturing technologies, equipment, computerized systems, and digital solutions.
• Partner with Manufacturing, Engineering, IT, Validation, Supply Chain, and other functions on IOPS projects.
• Facilitate project governance, risk assessments, quality decisions, and performance monitoring.
• Support the implementation of MES, electronic batch records, automation platforms, data integration systems, and advanced manufacturing technologies.
• Develop quality strategies, procedures, training materials, and governance frameworks while identifying opportunities for process simplification and digital innovation.

Requirements

• BS/BA in a scientific discipline or related field with 5+ years of relevant experience, or MS with 4+ years, in pharmaceuticals or a related industry.
• Experience with technology transfer principles and lifecycle management in a GMP-regulated environment.
• Understanding of computerized system implementation, validation, data integrity, 21 CFR Part 11, Annex 11, and GxP expectations.
• Familiarity with MES, electronic batch records, automation platforms, data historians, analytics tools, and system integrations.
• Knowledge of quality risk management and experience supporting continuous improvement or digital transformation in a regulated industry.
• Ability to manage multiple complex assignments independently and collaborate across technical and business functions.

Culture & Benefits

• Science-driven work focused on developing medicines for serious diseases.
• Inclusive workplace and equal opportunity employment.
• Potential benefits include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required by local law.