Regeneron · 12 hours ago
Vice President, Quality Assurance
Troy, NY
Full-time
Onsite
Director/Executive
$300K/yr - $500K/yr
20+ years expRegeneron is hiring a Vice President of Quality Assurance to lead strategic development and oversight of quality and compliance programs across their GMP operations. The role requires expertise in microbiology, data governance, and quality systems to ensure patient safety and product effectiveness while guiding cross-functional teams and driving innovation.
BiotechnologyPharmaceuticalBiopharma
Responsibilities
Oversee the development and implementation of a value-added microbiology program aligned to global regulatory and legal requirements
Monitor program performance via metrics; embed quality tools and risk management for continuous improvement
Stay ahead of evolving industry standards and proactively adapt program strategy and execution
Make science-based decisions that protect patient safety and ensure product quality and effectiveness
Act as a microbiology decision-maker with internal stakeholders, regulators, and corporate partners
Partner with lines of business to drive operational performance and compliance
Allocate resources and set high-performance standards to meet microbiological and organizational objectives
Lead strategic vision of the of the DGI Program, including engagement, culture, monitoring, and operational leadership
Develop and implement policies and procedures aligned with global regulatory standards and industrial best practices
Drive a mature data quality culture through change management and stakeholder engagement
Ensure DGI standards are continuously met and the function is properly resourced and equipped
Establish and lead quality systems across Regeneron with clear roles, responsibilities, workflows, and metrics
Provide leadership, tools, and coaching to quality system owners for effective execution
Oversee Right to Operate Review meetings; ensure management review expectations are met
Represent the Quality Management System Office in initiatives and program meetings, aligned to organizational goals
Coach and mentor staff; collaborate with Information Systems to support quality systems and the Quality Plan
Qualification
Required
Bachelor's degree
20+ years in a GMP-regulated industry (Biotech, Pharma, Medical Device)
At least 5+ years in a managerial capacity
Proven expertise in microbiology, data governance, and quality systems within GMP environments
Experience leading enterprise quality transformations across multi-site operations
Familiarity with digital quality systems, data analytics, and industry best-in-class tools
Strong knowledge of global regulatory standards and quality management principles
Demonstrated ability to drive change management and foster a culture of quality and compliance
Skilled in resource allocation, strategic planning, and decision-making in complex technical and regulatory settings
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
2026-02-02
2026-02-02
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