Remote Senior Manager, GCP Auditing & Quality Assurance

Regeneron; United Kingdom; Remote; GBP 90,000 - 130,000; Full time

Job summary

Regeneron is seeking a Senior Manager GCP Auditing to lead risk-based quality auditing and strengthen GCP compliance within the Global Development Quality Assurance team. The role supports a remote work model in the United Kingdom, coordinating with global development teams, external partners, and QA stakeholders to drive governance and continuous improvement.

The candidate will oversee end-to-end GCP audits, develop risk-based programs, and interact with senior leaders to resolve complex GxP

Qualifications

• Bachelor's degree with 8+ years of industry experience; Master's degree preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, EU 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 CROs.
• Ability to independently manage complex GxP compliance issues and high-value priorities.
• Willingness to travel 30-40% domestically and internationally.

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.

Skills

Leadership

Project management

Stakeholder management

Communication skills

Problem-solving

Independence/initiative

Attention to detail

GCP auditing experience

Education

Bachelor's degree

Master's degree

Job description

Regeneron is seeking a Senior Manager GCP Auditing to lead risk-based quality auditing and strengthen GCP compliance within the Global Development Quality Assurance team. The role supports a remote work model in the United Kingdom, coordinating with global development teams, external partners, and QA stakeholders to drive governance and continuous improvement.

The candidate will oversee end-to-end GCP audits, develop risk-based programs, and interact with senior leaders to resolve complex GxP