QA Compliance Specialist (Biotechnology)

Location: Raheen, Limerick, Ireland; onsite

Salary: €46,200–€75,400 annually

Company

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

What you will do

• Administer, review, and coordinate Change Control records throughout initiation, impact assessment, implementation, effectiveness verification, and closure.
• Provide quality oversight and review or approve Change Controls, deviation investigations, CAPA records, risk assessments, SOPs, work instructions, and related quality documentation.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, Supply Chain, MSAT, and other functions to assess and implement changes.
• Monitor open quality system records, escalate risks, and support timely completion of actions.
• Generate, monitor, and trend quality system metrics for management review and continuous improvement.
• Support investigations, corrective and preventive actions, training, and initiatives that improve quality system effectiveness and compliance.

Requirements

• Bachelor’s degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline; relevant experience may substitute for education.
• 3–5+ years of relevant experience in the pharmaceutical, biotechnology, or another regulated 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 for coordinating activities across multiple functions.
• Ability to work onsite in Raheen, Limerick, Ireland.

Nice to have

• Biologics manufacturing experience.

Culture & Benefits

• Science-driven environment focused on developing life-changing medicines.
• Inclusive workplace and equal opportunity employment.
• Competitive total rewards package that may include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during recruitment where required.