We are looking for a Manager, Global Development Auditing (GCP) to join our Global Development Quality Assurance (GDQA) team. In this role, you will use your expertise in Good Clinical Practice (GCP) and international regulations to lead risk-based quality audits and support compliance across Regeneron’s clinical development programs. You’ll play a vital part in safeguarding data integrity and ensuring our studies meet the highest quality standards, while also shaping practices through collaboration and mentorship. This role offers international exposure, diverse responsibilities, and the opportunity to be a trusted voice within GDQA.
A Typical Day
- Scheduling, preparing, conducting, and following up on global GCP audits in line with policies and procedures.
- Leading both internal and external audits across multiple regions.
- Representing GDQA on cross-functional teams and compliance initiatives.
- Supporting clinical studies with risk-based audit strategies.
- Interpreting policies, standards, and regulations to resolve complex compliance issues.
- Participating in regulatory inspections as part of the inspection room team.
- Guiding and mentoring GDQA staff through training and knowledge-sharing.
This Role May Be For You If
- You enjoy working independently while serving as a trusted “go-to” expert in GCP auditing.
- You thrive in a global role that includes 30–40% domestic and international travel.
- You are confident managing multiple types of audits, from site to vendor to process reviews.
- You’re motivated by problem-solving and interpreting regulatory requirements in multifaceted situations.
- You value teamwork and enjoy representing quality assurance in diverse teams.
- You take pride in mentoring colleagues and helping to build strong, knowledgeable teams.
To Be Considered
You will need a bachelor’s degree and at least 6 years of relevant proven experience, with 4 or more years directly passionate about GCP auditing. Experience conducting multiple audit types (site, vendor, and process) is encouraged. Strong knowledge of international regulations and an ability to manage audits with minimal supervision are essential.
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.S.-based 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.
