The Senior Manager Inspection Management is an integral part of the team that leads inspections through the prep, performance and follow-up of items requested by international regulatory agencies and partner audits. This position leads inspection content ensuring it is organized, current and readily accessible.
In this role, a typical day might include the following:
- The position requires you to be experienced with: GCP, GLP, and/or GPV Inspections.
- Support cross-functional teams in inspection readiness, ongoing inspections, and inspection follow-up and by performing inspection readiness visits at global clinical sites.
- Working with department leaders to build inspection readiness capabilities across the organization at non-manufacturing facilities.
- Leads teams implementing standard processes and improvements to assure teams are inspection ready at all times.
- Maintains and coordinates inspection content, including building and maintaining inspection content, including but not limited to, materials required in the event of inspection or audit and global regulations.
This role may be for you if:
- You can collaborate with cross-functional teams responding to incoming inquires during inspections and audits and ensure timely and accurate responses.
- Support cross-facility (Tarrytown, Basking ridge, Dublin, Uxbridge) and cross-GxP inspection activities.
- Provides advice and direction to company departments on quality and inspection related issues.
To be considered you must have experience in the following areas for consideration into this role: GCP, GLP, and/or GPV. You should have 4+ years of regulatory inspection experience in GxP, GCP preferred. Knowledge and experience preparing and conducting regulatory authority inspections with GCP, GLP, and GPV preferred. Knowledge and understanding of global GxP regulations with emphasis on GCP and ICH and have a solid understanding of clinical development, pharmacovigilance, laboratory practices
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$126,600.00 - $206,600.00