Senior Manager GCP Quality (Biotech)

Location: Dublin, Ireland; hybrid work model

Salary: 86,800.00–141,200.00 USD annually

Company

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

What you will do

• Lead risk-based quality management across assigned clinical trials.
• Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3.
• Manage quality issues, audit responses, corrective and preventive actions, and trend analysis.
• Partner with study leads, monitoring teams, clinical functions, and contract research organisations on site risks.
• Support inspection readiness, regulatory responses, and follow-up actions.
• Manage onboarding, development goals, coaching, performance discussions, and team administration.

Requirements

• Bachelor’s degree and eight years of relevant healthcare or pharmaceutical industry experience.
• Experience in quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice.
• Advanced knowledge of risk-based quality management, risk assessment, and compliance.
• Experience managing complex issues, regulatory inspections, and inspection readiness.
• Subject matter expertise, process ownership, training, presentation, and staff management experience.
• Process improvement, project management, prioritization, time management, communication, and collaboration skills.

Culture & Benefits

• Science-driven work focused on developing medicines for serious diseases.
• Culture centered on quality, integrity, continuous learning, and trusted partnerships.
• Competitive total rewards package, which may include bonuses, equity awards, retirement benefits, insurance, paid time off, and family support.
• Reasonable accommodations are available during the recruitment process where required.