Senior Manager GCP Quality

Location: Hybrid; multiple locations are being considered. Corporate headquarters: Tarrytown, New York, United States.

Salary: $134,400–$219,200 annually

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

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.
• Escalate significant quality events and trends and support inspection readiness, 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, prioritisation, time management, communication, collaboration, and advanced Microsoft Office skills.

Culture & Benefits

• Science-driven organisation focused on developing life-changing medicines.
• Collaborative work with clinical development teams, clinical functions, contract research organisations, and quality colleagues.
• Commitment to quality, integrity, continuous learning, and trusted partnerships.
• Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, 401(k) company match, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during the recruitment process where required.