Manager-Quality Assurance Auditor- GCP

Build our future together:
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.

When & where:
•    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

Discover your role:
•    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

This role requires:
•    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
 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$114,800.00 - $187,400.00