Senior GCP/GD Audit Lead – Remote

Regeneron Pharmaceuticals, Inc; Ireland; On-site; EUR 87,000 - 141,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager GD GCP Auditing in Ireland, with a remote work model. You will lead end-to-end GCP audits for global activities, develop risk-based programs, and drive improvements with QA and global development teams.

The role requires 8+ years in the industry, 5+ years GCP audit experience, and strong knowledge of FDA/EU/GCP. Travel 30–40% is expected, with leadership in complex compliance initiatives.

Qualifications

• Bachelor’s degree required; 8+ years in life sciences industry.
• 5+ years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA, EU, ICH, and GCP.
• Experience auditing process, site, vendor, and partner activities.
• Experience with regulatory inspections involving sites, sponsors, or CROs.
• Ability to manage complex GxP issues and high-priority audits.
• Strong leadership, project, and stakeholder management skills.
• 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 audits.
• Develop and execute risk-based audit programs for clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Represent QA on complex compliance projects and initiatives.
• Interpret policies, standards, and regulations to address issues.
• Support regulatory inspections and inspection room activities.
• Build trusted partnerships with stakeholders across functions.

Skills

Leadership

Project management

Stakeholder management

Communication

Negotiation

Independence

Detail orientation

Travel readiness

Education

Bachelor's degree

Master's degree preferred

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager GD GCP Auditing in Ireland, with a remote work model. You will lead end-to-end GCP audits for global activities, develop risk-based programs, and drive improvements with QA and global development teams.

The role requires 8+ years in the industry, 5+ years GCP audit experience, and strong knowledge of FDA/EU/GCP. Travel 30–40% is expected, with leadership in complex compliance initiatives.