Hybrid: Global GCP Quality Lead (Clinical Development)

BioSpace; Dublin (OH); Hybrid; USD 87,000 - 141,000; Full time

Job summary

Regeneron is a leading biotechnology company seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality oversight across global clinical trials within a hybrid work model. You will partner with study teams, CROs, and quality colleagues to ensure inspection readiness and strong quality controls.

You will guide protocol-stage risk assessments, manage quality issues and CAPAs, and mentor a team of quality professionals while upholding regulatory standards and

Qualifications

• Bachelor's degree and eight years of healthcare or pharmaceutical experience.
• Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience.
• Advanced risk-based quality management, risk assessment, and compliance knowledge.
• Experience managing complex issues, regulatory inspections, and inspection readiness.
• Subject matter expert, process owner, training, presentation, and staff management experience.
• Process improvement, project management, prioritisation, and time management skills.
• Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills.
• Strong communication, collaboration.

Responsibilities

• 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 actions, preventive actions, and trend analysis.
• Partner with study leads, monitoring teams, and contract research organisations on site risks.
• Escalate significant quality events and trends to Executive Quality Leadership.
• Support inspection readiness, responses, and follow-up actions across relevant functions.
• Manage onboarding, development goals, coaching, performance discussions, and team administration.
• You champion quality, integrity, continuous learning, and trusted partnerships.

Skills

Quality management

GCP knowledge

ICH E6 R3

Regulatory inspections

Communication skills

Project management

Time management

MS Office

Staff management

Education

Bachelor's degree

Job description

Regeneron is a leading biotechnology company seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality oversight across global clinical trials within a hybrid work model. You will partner with study teams, CROs, and quality colleagues to ensure inspection readiness and strong quality controls.

You will guide protocol-stage risk assessments, manage quality issues and CAPAs, and mentor a team of quality professionals while upholding regulatory standards and