Remote Senior GCP Auditing Lead - Global Development

BioSpace; Ireland (WV); Remote; USD 98,000 - 159,000; Full time

Job summary

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing and strengthen GCP compliance within the Global Development Quality Assurance team. The role supports a global development organization in a remote work model and involves travel 30-40% domestically and internationally.

The ideal candidate has a Bachelor’s degree with 8+ years in industry, 5+ years GCP auditing, and deep knowledge of FDA/EU regulations, ICH guidance, and GCP requirements.

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 and EU regulations, ICH guidance, and GCP requirements.
• Experience with process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or CROs.
• Ability to independently manage complex GxP issues and high-priority audits.
• Strong leadership, stakeholder management, collaboration, and negotiation skills.
• Excellent written and verbal communication and attention to detail.

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.

Skills

Leadership

Project management

Stakeholder management

Communication skills

Problem solving

Negotiation

Travel readiness

Education

Bachelor's degree

Master's degree preferred

Job description

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing and strengthen GCP compliance within the Global Development Quality Assurance team. The role supports a global development organization in a remote work model and involves travel 30-40% domestically and internationally.

The ideal candidate has a Bachelor’s degree with 8+ years in industry, 5+ years GCP auditing, and deep knowledge of FDA/EU regulations, ICH guidance, and GCP requirements.