Vice President, Quality Assurance
Regeneron
5 hours ago
On-site
Troy, NY
Operations
Microbiology Program Leadership
- Oversee 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.
Data Governance & Integrity (DGI) Program Leadership
- Lead the DGI Program’s strategic vision, including engagement, culture, monitoring, and operational leadership.
- Develop and implement policies and procedures aligned with global regulatory standards and industry 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.
Quality Systems Oversight
- Establish and lead quality systems 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.
This Role Might Be For You If You Have
- 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.
Qualifications
- 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).
Benefits (U.S., location-dependent)
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application Instructions
- Apply now to be considered for the role.
Salary Range (annually)
- $300,000.00 - $500,000.00
- Oversee 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.
Data Governance & Integrity (DGI) Program Leadership
- Lead the DGI Program’s strategic vision, including engagement, culture, monitoring, and operational leadership.
- Develop and implement policies and procedures aligned with global regulatory standards and industry 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.
Quality Systems Oversight
- Establish and lead quality systems 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.
This Role Might Be For You If You Have
- 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.
Qualifications
- 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).
Benefits (U.S., location-dependent)
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application Instructions
- Apply now to be considered for the role.
Salary Range (annually)
- $300,000.00 - $500,000.00