Senior GCP Audit Lead - Global Development, Remote Ireland

Regeneron Ireland; Ireland; Remote; EUR 130,000 - 170,000; Full time

Job summary

Regeneron Ireland is seeking a Senior Manager GD GCP Auditing to join Global Development Quality Assurance. This remote role leads risk-based quality auditing activities and ensures GCP compliance across global development teams, external partners, and quality stakeholders.

You will guide end-to-end GCP audits, develop audit programs, and support regulatory inspections. Travel 30-40% domestically and internationally is expected in a dynamic, collaborative environment.

Qualifications

• Bachelor’s degree with 8+ years in the industry.
• 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.

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.
• You thrive in a dynamic environment and build trusted stakeholder partnerships.

Skills

GCP auditing

Regulatory knowledge

Leadership

Project management

Stakeholder management

Communication skills

Travel willingness

Education

Bachelor’s degree in related field

Master’s degree preferred

Job description

Regeneron Ireland is seeking a Senior Manager GD GCP Auditing to join Global Development Quality Assurance. This remote role leads risk-based quality auditing activities and ensures GCP compliance across global development teams, external partners, and quality stakeholders.

You will guide end-to-end GCP audits, develop audit programs, and support regulatory inspections. Travel 30-40% domestically and internationally is expected in a dynamic, collaborative environment.