QC Business Process Specialist (Biopharma)

Location: Waterford, Ireland; onsite

Salary: €48,000–€64,000 per year

Company

hirify.global is an R&D-driven, AI-powered biopharma company developing medicines and vaccines.

What you will do

• Support the QC Microbiology team by improving, standardizing, and maintaining laboratory business processes.
• Contribute to an effective compliance program and ensure operations align with pharmaceutical regulations and international standards.
• Manage SOPs, procedures, and compliance documentation.
• Support deviation, CAPA, and compliance incident investigations to prevent recurrence.
• Provide compliance training and guidance to laboratory employees.
• Support LIMS and other digital systems used by the laboratory.

Requirements

• Experience ensuring compliance with local, national, and international pharmaceutical regulations and standards.
• Experience managing internal audits and external regulatory inspections, including preparation, execution, and follow-up.
• In-depth knowledge of FDA, EMA, ICH, and other pharmaceutical regulations, guidelines, and standards.
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions.
• Strong verbal and written communication skills and careful attention to documentation accuracy.
• Ability to manage multiple compliance projects and deliver them on time.

Culture & Benefits

• Work in a pioneering biopharma environment focused on patient-informed drug development and AI-powered science.
• Collaborate with diverse, multidisciplinary teams.
• Access career growth opportunities across scientific, leadership, and cross-functional paths.
• Receive health and well-being benefits, including healthcare coverage.
• Benefit from 14 weeks of gender-neutral parental leave.