Senior GCP Quality Lead — Global Development (Hybrid)

BioSpace; Kuah; Hybrid; MYR 351,000 - 571,000; Full time

Job summary

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

The role requires a Bachelor's degree and eight years of healthcare/pharmaceutical experience, plus strong knowledge of GCP, risk management, and regulatory

Qualifications

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

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

Risk assessment

Communication

Collaboration

Education

Bachelor's degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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

The role requires a Bachelor's degree and eight years of healthcare/pharmaceutical experience, plus strong knowledge of GCP, risk management, and regulatory