Remote GCP Auditing Senior Manager, Global Development QA

BioSpace; Ireland (WV); Remote; USD 97,000 - 158,000; Full time

Job summary

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing activities within the Global Development Quality Assurance team, supporting the global development organization in a remote work model.

You will oversee end-to-end GCP audits, develop audit programs for clinical studies, and drive issue resolution while collaborating with external partners and quality stakeholders worldwide.

Qualifications

• Bachelor's degree with 8+ years of relevant industry experience; Masters degree preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, European Union 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 Contract Research Organizations.
• Ability to independently manage complex GxP compliance issues and high-value priorities.

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.
• Representing 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

Project management

Stakeholder management

Negotiation

Communication skills

Attention to detail

Independent work

Education

Bachelor's degree

Master's degree

Job description

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing activities within the Global Development Quality Assurance team, supporting the global development organization in a remote work model.

You will oversee end-to-end GCP audits, develop audit programs for clinical studies, and drive issue resolution while collaborating with external partners and quality stakeholders worldwide.