Senior Manager, GCP Quality & Risk - Global Development

BioSpace; Uxbridge (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team in a hybrid work model. You will lead risk-based quality management across clinical trials and collaborate with study teams, CROs, and quality colleagues to ensure inspection readiness and continuous improvement.

You will drive risk-based QA activities, manage investigations, and mentor a team.

Qualifications

• Bachelor's degree and eight years relevant healthcare or pharmaceutical industry 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.

Skills

Quality management

GCP/GVP experience

Risk assessment

Regulatory inspections

Staff management

Project management

Microsoft Office

Communication & collaboration

Education

Bachelor's degree in healthcare or life sciences

Job description

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team in a hybrid work model. You will lead risk-based quality management across clinical trials and collaborate with study teams, CROs, and quality colleagues to ensure inspection readiness and continuous improvement.

You will drive risk-based QA activities, manage investigations, and mentor a team.