Manager Global Development Auditing (GCP)

We are seeking a Manager, Global Development Auditing (GCP) to join our Global Development Quality Assurance (GDQA) team. In this role, you’ll play a pivotal part in protecting data integrity and ensuring compliance with Good Clinical Practice (GCP) across Regeneron’s clinical programs.

You will be responsible for leading audits from start to finish — planning, execution, and reporting — with a particular focus on site investigator audits across Europe. This position offers the opportunity to work globally, collaborate across teams, and serve as a trusted quality leader.

A Typical Day

• Leading investigator site audits in Europe and the U.S. to assess compliance with GCP standards.
• Conducting vendor and internal process audits across global operations.
• Leading the full audit cycle, including preparation, on-site execution, reporting, and follow-up.
• Interpreting regulations and identifying solutions to complex compliance issues.
• Partnering with GDQA colleagues and cross-functional teams on quality initiatives.
• Supporting regulatory inspections as part of the inspection room team.
• Contributing to staff development by mentoring and sharing procedures.

This Role May Be For You If

• You have strong experience conducting GCP audits and can expertly lead investigator site audits.
• You’re diligent and take pride in writing clear, high-quality audit reports.
• You’re comfortable balancing independence with cross-functional collaboration.
• You enjoy solving compliance challenges and applying QMS knowledge to practical solutions.
• You thrive in a role that combines structure with the variety of international exposure.

To Be Considered

You’ll need a bachelor’s degree and at least 6 years of relevant proven experience, including 4+ years in GCP auditing. Experience leading multiple audit types — especially investigator site audits — is essential. Familiarity with quality management systems (QMS) is required, along with a strong grasp of international regulations. This position requires 30–40% travel across the EU and occasionally the U.S.

At Regeneron, we develop an inclusive, diverse culture where everyone’s contributions are valued. We offer comprehensive benefits tailored to your location, which may include health and wellness programs, equity awards, annual bonuses, fitness centers, and generous paid time off.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.