Senior Manager, GCP Auditing — Remote Quality Leader

Regeneron Pharmaceuticals, Inc; United States; On-site; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team. This remote role oversees risk-based quality auditing and strengthens GCP compliance across global development activities.

You will lead end-to-end audits, develop programs, and collaborate with internal teams, external partners, and quality stakeholders to ensure regulatory readiness and scientific integrity at scale.

Qualifications

• Bachelor’s degree required; 8+ years in industry; Master’s degree preferred.
• Direct GCP audit experience (5+ years) is essential.
• Expert knowledge of FDA, EU regulations, ICH and GCP.
• Experience with process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigators, sponsors or CROs.

Responsibilities

• Lead end-to-end GCP audits across internal and external global activities.
• Schedule, conduct, report, and follow up on routine and directed audits.
• Develop and execute risk-based audit programs for assigned clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Represent Quality Assurance on complex compliance projects and initiatives.
• Interpret policies, standards, and regulations to address critical issues.
• Support regulatory inspections and inspection room activities.
• Thrive in a dynamic environment and build trusted stakeholder partnerships.

Skills

Leadership

Project management

Stakeholder management

Communication

Negotiation

Problem solving

Attention to detail

Travel readiness

Education

Bachelor’s degree

Master’s degree preferred

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team. This remote role oversees risk-based quality auditing and strengthens GCP compliance across global development activities.

You will lead end-to-end audits, develop programs, and collaborate with internal teams, external partners, and quality stakeholders to ensure regulatory readiness and scientific integrity at scale.