Manager-Quality Assurance Auditor- GCP

Scorpion Therapeutics; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Regeneron is seeking a Manager, GCP Auditing within Global Development Quality Assurance to lead risk-based GCP audits across investigator sites, vendors, and internal processes worldwide.

You will interpret FDA, EU, and ICH regulations, manage end-to-end audits, support regulatory inspections, and collaborate with cross-functional teams to ensure studies meet compliance.

Qualifications

• Bachelor's degree with 6+ years of industry experience including at least 4 years in GCP auditing.
• Strong knowledge of FDA, EU regulations, and ICH E6 R3.
• Demonstrated project and stakeholder management skills.

Responsibilities

• Lead end-to-end GCP audits across investigator sites, vendors, and internal processes.
• Interpret FDA, EU, and ICH regulations and ensure audit findings are appropriately addressed.
• Collaborate with cross-functional teams and support regulatory inspections.

Skills

GCP auditing

Risk-based auditing

Stakeholder management

Regulatory knowledge

Education

Bachelor's degree

Job description

Manager, GCP Auditing within Regeneron's Global Development Quality Assurance team, responsible for leading risk-based GCP audits across investigator sites, vendors, and internal processes globally.

Primary objectives include ensuring clinical studies meet GCP compliance standards, supporting regulatory inspections, and developing audit strategies.

Responsibilities encompass end-to-end audit management, interpreting FDA, EU, and ICH regulations, and collaborating with cross-functional teams.

Requirements: Bachelor's degree with over 6 years of industry experience, including at least 4 years in GCP auditing; strong knowledge of FDA, EU regulations, and ICH E6 R3; demonstrated project and stakeholder management skills.

Preferred: Experience in risk-based clinical audit strategy development and supporting complex compliance projects.

High-Value: Clinical development audits supporting biopharma trials, with a focus on global regulatory standards, on-site and remote work, and 30-40% travel.

Work setup: Remote, with significant travel.