Address The Senior Manager, Global Development Quality Inspection Management (GDQIM) will provide project management support of the processes managed within the team. We believe you will support the Inspection Management Leads (IMLs) with the effective management of GCP, GVP and GLP inspections. We assume you will engage with key partners, build strategic partnerships working and liaising with Clinical teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials. We expect that you to be assigned to line manage, coach and/or mentor more junior members of the team. The GDQIM team is tasked with effective planning, preparation, conduct and follow-up of GCP, GVP and GLP inspections conducted by regulatory authorities. In this role, a typical day might include the following:
Ensuring and responsible for the notification of all relevant internal and external partners of upcoming and/or anticipated regulatory inspections.
Working with Inspection Management Leads (IMLs) in preparing, managing, and integrating Inspection Management processes and training activities into the clinical development programs and all relevant collaborators.
Partner with the IMLs in providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key partners) in advance of an impending inspection.
Collaborate with the IMLs in identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
Working with the IMLs in preparing, managing, and conducting inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits.
Supporting the front/back room lead/co-lead, by tracking requests and inquiries, coordinating/presenting requests for responses, and collecting responses from relevant personnel during any regulatory inspection conducted worldwide. This role might be for you if:
If you able to navigate a global environment and in ambiguous situations
If you are a standout colleague and contributor with global teams
If you can provide consultation, guidance, training, and support in respect to compliance with applicable international regulations, practices, and guidelines
To be considered, we expect candidates to have at a minimum a Bachelor's degree with a minimum of 8 years of pharmaceutical industry experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). We also require colleagues to be onsite in one of our New York Metro offices a few days as week.
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.
