Manager-Quality Assurance Auditor- GCP- (Remote US)
About The Position
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.
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 complex decisions with a sense of urgency
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
