Manager-Quality Assurance Auditor- GCP- (Remote US)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Global Development Quality Assurance (GDQA) team as a Manager, GCP Auditing and support clinical development activities across our global portfolio. You will build strategic partnerships leading risk-based quality audits across investigator sites, service providers, and internal processes, ensuring our clinical studies meet the highest standards of GCP compliance. Collaborate with study teams, cross-functional partners, and regulatory colleagues worldwide to make a meaningful difference to patients.

Location: US (Multiple locations considered)
Work model: Remote
Travel: 30–40% domestically and internationally

About the Role

• Own the end-to-end audit process — scheduling, preparing, conducting, reporting, and following up on routine and directed audits
• Lead a range of audit types across sites, vendors, license partners, and internal processes globally
• Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve GCP compliance issues
• Represent GDQA on cross-functional teams and complex compliance projects spanning multiple departments
• Interpret regulations and quality standards, evaluating critical issues that fall outside existing guidance
• Support clinical study teams by developing and implementing risk-based audit strategies
• Step into regulatory inspections as part of the control or inspection room team when needed
• Mentor and help onboard new GDQA staff, sharing your auditing expertise

Requirements

• Bachelor's degree with 6+ years of relevant industry experience, including 4+ years of direct GCP audit experience
• Background supporting risk-based audit strategy development for clinical studies
• Experience applying FDA and EU regulations including ICH E6 R3 and applicable standards
• Ability to effectively manage multiple complex priorities and make decisions with urgency
• Strong track record of project management, stakeholder management, collaboration, and negotiation of complex situations

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits, 401(k) company match
• Health and wellness programs, fitness centers
• Insurance benefits (e.g., medical, dental, vision, life, and disability)
• Paid time off and family support benefits

Pay

Salary Range (annually): $114,800.00 - $187,400.00