Senior Manager, Global GCP Auditing - Audit Leader (Remote)

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 134,000 - 219,000; Full time

Benefits offered by this job

Bonus programs

Equity awards

401(k)

Health benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager GD GCP Auditing to lead risk-based GCP auditing within Global Development Quality Assurance. This remote role collaborates with development teams, external partners, and quality stakeholders to strengthen compliance across global activities.

You will oversee end-to-end audits, develop risk-based programs, and support regulatory inspections, while guiding senior leaders and building strong partnerships in a dynamic environment.

Qualifications

• Bachelor's degree with 8+ years of relevant 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.
• Strong leadership, project management, and stakeholder negotiation skills.
• Excellent written and verbal communication; ability to work independently in ambiguity.

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.
• Build trusted stakeholder partnerships and work with senior leaders.

Skills

GCP auditing

FDA regulations

ICH guidelines

Vendor audits

Stakeholder management

Travel 30-40%

Education

Bachelor's degree

Master's degree preferred

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager GD GCP Auditing to lead risk-based GCP auditing within Global Development Quality Assurance. This remote role collaborates with development teams, external partners, and quality stakeholders to strengthen compliance across global activities.

You will oversee end-to-end audits, develop risk-based programs, and support regulatory inspections, while guiding senior leaders and building strong partnerships in a dynamic environment.