Senior GCP Quality Lead — Global Development

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

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across clinical trials in a hybrid work environment. You will collaborate with study teams, CROs, and quality colleagues to ensure quality, compliance, and readiness for inspections worldwide.

The role requires a Bachelor’s degree and eight years of healthcare or pharmaceutical experience, with deep knowledge of GCP, risk management, and regulatory expectations, enabling

Qualifications

• Bachelor's degree in a life sciences field and at least 8 years of healthcare or pharmaceutical experience.
• Strong knowledge of Good Clinical Practice and regulatory expectations.
• Expertise in quality risk management and compliance.
• Experience with inspections, CAPA, and cross-functional collaboration.

Responsibilities

• Lead risk-based quality management across 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 CROs on site risks.
• Escalate significant quality events and trends to Executive Quality Leadership.
• Support inspection readiness, responses, and follow-up actions across relevant functions.

Skills

Quality management

Risk assessment

Regulatory inspections

Communication

Collaboration

Project management

Time management

Training & staff management

Process improvement

Stakeholder management

Education

Bachelor's degree

Job description

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across clinical trials in a hybrid work environment. You will collaborate with study teams, CROs, and quality colleagues to ensure quality, compliance, and readiness for inspections worldwide.

The role requires a Bachelor’s degree and eight years of healthcare or pharmaceutical experience, with deep knowledge of GCP, risk management, and regulatory expectations, enabling