Senior Manager GD GCP Auditing

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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.

Requirements

• Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
• Experience conducting audit types including process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
• Ability to independently manage complex GxP compliance issues and high-value priorities.
• Strong leadership skills with experience interfacing with senior leaders.
• Excellent project management, stakeholder management, collaboration, and negotiation skills.
• Strong problem-solving, written, and verbal communication skills.
• Ability to work independently, take initiative, and perform effectively in ambiguous environments.
• High attention to detail, accuracy, and organizational awareness.
• Willingness to travel 30-40% domestically and internationally.

Pay

Salary Range (annually): $134,400.00 – $219,200.00