Senior Manager, Global Development Quality Assurance (GCP)

Regeneron Pharmaceuticals, Inc.

Job Overview

Location

Remote - United States

Job Type

Full-time

Full Job Description

📋 Description

• The Senior Manager, Global Development Quality Assurance (GCP) at Regeneron Pharmaceuticals, Inc. is a key leadership role responsible for supervising, guiding, and leading one of the company’s Good Clinical Practice (GCP) audit programs, ensuring compliance with global regulatory standards in drug development.
• Day-to-day responsibilities include managing and developing direct reports through monthly meetings and performance assessments, scheduling and conducting internal and external GxP audits globally, preparing audit reports, following up on findings, and representing the department in cross-functional meetings to provide audit and compliance input.
• The role involves leading the identification of quality and compliance issues, driving process improvements, interpreting and assisting in the development of policies and standards, and providing education and training to GDQA and other Global Development departments.
• The position offers the opportunity to contribute to a fast-growing, science-driven organization dedicated to improving patient lives worldwide, with the chance to develop strategic partnerships, lead risk-based quality auditing initiatives, and grow as a people manager in a high-impact, global pharmaceutical environment.

🎯 Requirements

• Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience in pharmaceuticals, biotechnology, or regulated industries.
• Deep knowledge of FDA, EU regulations, ICH guidance, and other regulations affecting drug development and post-authorization safety monitoring.
• 5+ years of direct people management experience and proven experience in GCP auditing.
• Excellent communication and people management skills, with the ability to collaborate effectively across all organizational levels and with external partners such as CROs and investigator sites.
• Experience with FDA or other regulatory inspections of investigator sites, sponsors, or CROs.
• Strong leadership, problem-solving, project management, and negotiation skills, with a track record of managing complex situations and driving standardization and best practices.

🏖️ Benefits

• Competitive annual salary range of $134,400.00 to $219,200.00, based on role, location, and experience.
• Comprehensive total rewards package including annual bonuses, equity awards, pension or retirement benefits, and 401(k) company match.
• Health and wellness programs, fitness centers, and insurance benefits (medical, dental, vision, life, and disability).
• Paid time off and family support benefits.
• Opportunity for professional growth and development in a science-driven, inclusive organization committed to patient impact.

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Regeneron Pharmaceuticals, Inc.

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About Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc. is a biotechnology company that develops, manufactures and markets antibody-based medicines for ophthalmology, oncology, immunology, infectious disease and rare disorders. Founded in 1988 and headquartered in Tarrytown, New York, Regeneron uses its proprietary VelociSuite technologies to discover fully human monoclonal antibodies and other therapeutic proteins. Its FDA-approved products include EYLEA, Dupixent, Libtayo, Praluent and Kevzara, while a broad pipeline addresses asthma, cancer, Ebola, COVID-19 and other diseases. The company operates research, manufacturing and clinical facilities across the United States and collaborates with Sanofi, Bayer and other partners worldwide.

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