Regeneron · 1 month ago
Associate Director Inspection Management (GCP)
Armonk, NY
Full-time
Onsite
Senior Level, Lead/Staff
$155K/yr - $253K/yr
10+ years expRegeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines. The Associate Director, Global Development Quality Inspection Management is responsible for managing GCP, GVP, and GLP inspections, engaging with stakeholders, and supporting clinical study teams with inspection preparation activities.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections
Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders
Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection
Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups
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
Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs
Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide
Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders
Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners
Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics
Qualification
Required
Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience
Advanced knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities
Extensive experience with participating in, and supporting, Regulatory Agency Inspections of Investigator Sites, Sponsors and Clinical Research Organizations (CROs) in a GxP environment, including inspection preparation, facilitation, and follow-up
Effective management of interpersonal relationships, stakeholder engagement, and collaborations
Demonstrated ability to interface and collaborate effectively with other Managers and Directors within, and external to, the organization
Extensive experience in providing training and presenting information on key quality and regulatory compliance information
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)
Experience in training, supervising, line management, mentoring and development of staff, and leading a small team
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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