Senior QA Audit Architect, Remote GCP Strategy

Regeneron; United Kingdom; On-site; GBP 90,000 - 140,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Audit Strategy in Global Development Quality Assurance to lead risk-based audit planning across therapeutic areas and studies. This remote-friendly role collaborates with cross-functional teams and external auditors while ensuring audits align with approved programs and timelines.

You will drive strategic programs, identify trends from audit outcomes, and present findings to Global Development leadership.

Qualifications

• Bachelor’s degree with 8+ years of relevant industry experience.
• 5+ years of GCP audit strategy or audit experience.
• Knowledge of FDA, EU, and ICH GCP regulations and guidance.
• Experience supporting or participating in regulatory inspections.
• Strong project management and stakeholder management capabilities.
• Excellent written and verbal communication skills with senior audiences.

Responsibilities

• Lead risk-based audit planning across therapeutic areas and studies
• Drive strategic audit programs using risk indicators from study teams
• Ensure audits align with approved programs and scheduled timelines
• Manage audit outcomes to identify trends and communicate risks
• Represent quality assurance on complex cross-functional initiatives
• Deliver reports and metrics to Global Development leadership
• Collaborate effectively with stakeholders across global functions
• Navigate ambiguity while prioritizing multiple complex activities

Skills

GCP audit strategy

Stakeholder management

Project management

Regulatory inspections

Communication skills

Education

Bachelor’s degree

Job description

Regeneron is seeking a Senior Manager, GCP Audit Strategy in Global Development Quality Assurance to lead risk-based audit planning across therapeutic areas and studies. This remote-friendly role collaborates with cross-functional teams and external auditors while ensuring audits align with approved programs and timelines.

You will drive strategic programs, identify trends from audit outcomes, and present findings to Global Development leadership.