Global GCP Quality Lead, Clinical Development

BioSpace; Uxbridge (MA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development 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 uphold quality across development programs.

You will escalate significant quality events to leadership, support inspection readiness, and contribute to team onboarding, coaching, and performance discussions, fostering a culture of quality and partnership.

Qualifications

• Bachelor's degree or higher in a healthcare, pharmaceutical, or related field.
• 8+ years of healthcare or pharmaceutical experience with quality/compliance
• Experience in Good Clinical Practice or Good Pharmacovigilance Practice

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, CAPA, and trend analysis.
• Partner with study leads, monitoring teams, and CROs on site risks.
• Escalate significant quality events to Executive Quality Leadership.
• Support inspection readiness, responses, and follow-up actions across functions.
• Lead onboarding, development goals, coaching, and performance discussions for the team.
• Champion quality, integrity, continuous learning, and trusted partnerships.

Skills

Quality management

Clinical development

GCP/GVP

Risk management

Regulatory inspections

Staff management

Project management

MS Office

Communication

Education

Bachelor's degree

Job description

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development 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 uphold quality across development programs.

You will escalate significant quality events to leadership, support inspection readiness, and contribute to team onboarding, coaching, and performance discussions, fostering a culture of quality and partnership.