Senior GCP Auditing Lead (Remote) — Global Development

BioSpace; United States; On-site; USD 134,000 - 219,000; Full time

Job summary

Regeneron is seeking a Senior Manager GD GCP Auditing to lead end-to-end GCP audits across global development activities from a remote work model. You will report to Global Development Quality Assurance, develop risk-based audit programs, drive issues resolution, and collaborate with internal teams and external partners on complex compliance initiatives.

The ideal candidate has 8+ years in industry with 5+ years of GCP audit experience, deep FDA/EU/ICH/GCP knowledge, and readiness to travel

Qualifications

• 8+ years of industry experience with 5+ years in GCP audit.
• Expert knowledge of FDA, EU, ICH, and GCP requirements.
• Experience conducting process, site, vendor, and partner audits.

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

Stakeholder management

Project management

Education

Bachelor's degree

Masters preferred

Job description

Regeneron is seeking a Senior Manager GD GCP Auditing to lead end-to-end GCP audits across global development activities from a remote work model. You will report to Global Development Quality Assurance, develop risk-based audit programs, drive issues resolution, and collaborate with internal teams and external partners on complex compliance initiatives.

The ideal candidate has 8+ years in industry with 5+ years of GCP audit experience, deep FDA/EU/ICH/GCP knowledge, and readiness to travel