Regeneron · 22 hours ago
Vice President, Global Development Quality
Tarrytown, NY
Full-time
Hybrid
Director/Executive
$300K/yr - $500K/yr
20+ years expRegeneron is seeking a Vice President of Global Development Quality to lead end-to-end quality oversight across GCP, GVP, and GLP. This role involves setting strategy, building scalable quality systems, and ensuring inspection readiness and global compliance while driving continuous improvement across various development areas.
BiotechnologyPharmaceuticalBiopharma
Responsibilities
Providing strategic leadership for Global Development Quality across GCP, GVP, and GLP, aligned with business objectives and regulatory requirements
Owning the Global Development Quality Management System (QMS): design, implementation, maintenance, governance, and continuous improvement
Leading inspection readiness and hosting global regulatory inspections; overseeing responses and driving timely, sustainable CAPAs
Directing the internal and external audit program (including vendor audits and CRO/central lab oversight) and ensuring risk-based coverage
Monitoring evolving regulations, standards, and guidances; updating policies, SOPs, and procedures and communicating changes to stakeholders
Partnering with R&D and Development functions to embed quality by design into clinical and nonclinical programs, processes, and deliverables
Overseeing CSV for GxP-relevant systems (e.g., clinical, safety, lab systems) to ensure compliance with global expectations (e.g., 21 CFR Part 11, EU Annex 11)
Establishing and reporting quality metrics and KPIs; using data to drive performance, reliability, and continuous improvement
Identifying and mitigating compliance and patient-safety risks; leading robust root cause analysis and CAPA effectiveness verification
Building and developing a high-performing Quality team; setting vision, fostering accountability, and elevating inspection readiness culture
Influencing senior leaders and cross-functional partners; shaping decisions with quality risk-benefit perspectives
Define and execute Global Development Quality strategy and roadmap
Govern policies, standards, and procedures to meet and exceed global regulatory expectations
Ensure compliance with FDA, EMA, ICH, GLP, GCP, GVP, and other applicable requirements
Drive harmonization, scalability, and efficiency across quality systems and processes
Lead change management for new/updated regulations and internal process improvements
Maintain robust vendor oversight frameworks and qualification/monitoring processes
Sponsor initiatives that enhance data integrity, documentation quality, and audit trails
Communicate quality outcomes, risks, and progress to executive stakeholders
Qualification
Required
Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree (Master's or PhD) preferred
20+ years of experience in relevant GxP areas (GCP, GVP, GLP), with at least 50% in quality management/quality assurance
5+ years in senior leadership roles with direct oversight of global quality systems and inspection readiness
Demonstrated success leading regulatory inspections, complex audits, and enterprise CAPA programs
Experience governing QMS and CSV for GxP systems in a biopharma setting
Preferred
Experience in biologics and/or advanced modalities
Proven track record of building global quality organizations and scalable processes
Familiarity with digital quality tools, data integrity frameworks, and KPI-driven performance management
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)
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
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