Sr. Mgr Inspection Management

Regeneron PharmaceuticalsArmonk, NY
3dOnsite

About The Position

As a Senior Manager in GDQIM, you will help coordinate inspection‑related activities across our GCP, GVP, and GLP programs. You’ll work closely with Inspection Management Leads (IMLs), Clinical Study Teams, and partners across Global Development Quality. We aim to create a supportive, well‑prepared environment for inspections, and this role contributes directly to that effort. In a typical day, you will: We work together to keep our teams aligned, informed, and ready for regulatory interactions. Your day may involve: Sharing inspection notifications with internal and external partners. Supporting IMLs as we plan readiness activities and prepare study teams. Helping teams identify areas that may need attention ahead of inspections. Participating in preparation sessions, including mock inspections and training. Coordinating inspection requests and responses so information remains clear and timely. Preparing short daily summaries during inspections and supporting follow‑up actions. Maintaining GDQIM documentation, tools, and shared systems. Contributing to lessons‑learned reviews and small improvements that benefit future inspections. This role might be for you if you: We value people who bring clarity, collaboration, and steadiness to complex work. You may be a good fit if you: Have experience with GCP and/or GVP and feel comfortable supporting inspection activities. Work well with a wide range of colleagues and communicate with clarity and consideration. Enjoy organising information, supporting decision‑making, and helping teams prepare. Approach challenges with curiosity, sound judgement, and a practical mindset. Are interested in supporting colleagues’ growth and fostering a thoughtful working environment.

Requirements

  • A Bachelor’s degree and 8+ years of relevant healthcare or pharmaceutical experience.
  • Experience in quality/compliance or Clinical Development with working knowledge of GCP/GVP.
  • Experience supporting, mentoring, or guiding team members.

Responsibilities

  • Sharing inspection notifications with internal and external partners.
  • Supporting IMLs as we plan readiness activities and prepare study teams.
  • Helping teams identify areas that may need attention ahead of inspections.
  • Participating in preparation sessions, including mock inspections and training.
  • Coordinating inspection requests and responses so information remains clear and timely.
  • Preparing short daily summaries during inspections and supporting follow‑up actions.
  • Maintaining GDQIM documentation, tools, and shared systems.
  • Contributing to lessons‑learned reviews and small improvements that benefit future inspections.

Benefits

  • health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • fitness centers
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
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