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RENSS - GLOBAL VIEW, United States of America
Onsite
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.
In this role, a typical day might include the following:
Microbiology Program Leadership:
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.
Data Governance & Integrity (DGI) Program Leadership:
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.
Quality Systems Oversight:
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.
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.
To be considered for this role you must hold a Bachelor’s degree and 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)