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.

Does this sound like you?

Apply now to take your first step towards living the Regeneron Way.

We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.

S., the salary ranges provided are shown in accordance with U.

S.

law and apply to U.

positions.

For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency.

If you are outside the U.

S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.

Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.