[Hiring] Quality Assurance Manager @Regeneron Pharmaceuticals

Role Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, GCP Auditing to join our Global Development Quality Assurance (GDQA) team, supporting 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, while collaborating with study teams, cross-functional partners, and regulatory colleagues around the world.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location: US (Multiple locations are being considered for this role)
• Work model/flexibility: Remote
• Travel percentage: Ability to travel 30–40% of the time, both domestically and internationally

Responsibilities

• 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 a variety of 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

Qualifications

• 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 complex decisions with a sense of urgency
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations

Benefits

• 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
• Family support benefits

Salary Range

$114,800.00 - $187,400.00