Vice President, Quality Assurance

Role Summary

Regeneron is hiring! The Vice President, Quality Assurance will lead the strategic development, execution, and oversight of key quality and compliance programs across Regeneron GMP operations. This role blends deep expertise in microbiology, data governance, and quality systems to safeguard patient safety, ensure product effectiveness, and uphold global regulatory compliance. This position will guide cross-functional teams, drive innovation, and champion a culture of quality across the organization.

Responsibilities

• Microbiology Program Leadership: Oversee the development and implementation of a value-added microbiology program aligned to global regulatory and legal requirements.
• Microbiology Program Leadership: Monitor program performance via metrics; embed quality tools and risk management for continuous improvement.
• Microbiology Program Leadership: Stay ahead of evolving industry standards and proactively adapt program strategy and execution.
• Microbiology Program Leadership: Make science-based decisions that protect patient safety and ensure product quality and effectiveness.
• Microbiology Program Leadership: Act as a microbiology decision-maker with internal stakeholders, regulators, and corporate partners.
• Microbiology Program Leadership: Partner with lines of business to drive operational performance and compliance.
• Microbiology Program Leadership: Allocate resources and set high-performance standards to meet microbiological and organizational objectives.
• Data Governance & Integrity (DGI) Program Leadership: Lead strategic vision of the DGI Program, including engagement, culture, monitoring, and operational leadership.
• Data Governance & Integrity (DGI) Program Leadership: Develop and implement policies and procedures aligned with global regulatory standards and industrial best practices.
• Data Governance & Integrity (DGI) Program Leadership: Drive a mature data quality culture through change management and stakeholder engagement.
• Data Governance & Integrity (DGI) Program Leadership: Ensure DGI standards are continuously met and the function is properly resourced and equipped.
• Quality Systems Oversight: Establish and lead quality systems across Regeneron with clear roles, responsibilities, workflows, and metrics.
• Quality Systems Oversight: Provide leadership, tools, and coaching to quality system owners for effective execution.
• Quality Systems Oversight: Oversee Right to Operate Review meetings; ensure management review expectations are met.
• Quality Systems Oversight: Represent the Quality Management System Office in initiatives and program meetings, aligned to organizational goals.
• Quality Systems Oversight: Coach and mentor staff; collaborate with Information Systems to support quality systems and the Quality Plan.

Qualifications

• Required: Bachelor’s degree; 20+ years in a GMP-regulated industry (Biotech, Pharma, Medical Device), including at least 5+ years in a managerial capacity, or equivalent education and experience.
• 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.

Skills

• Microbiology
• Data governance
• Quality systems
• Regulatory compliance
• Change management
• Strategic planning
• Resource allocation
• Data analytics

Education

• Bachelor's degree in a relevant field (required).