Vice President, Global Development Quality

Company: Regeneron Pharmaceuticals, Inc.
Location: Tarrytown
Posted on: February 13, 2026

Job Description:

Regeneron is seeking a Vice President of Global Development Quality to lead end-to-end quality oversight across GCP, GVP, and GLP, including computer system validation supporting these GxPs. This senior leader will set the strategy, build and evolve scalable quality systems, and ensure inspection readiness and global compliance (FDA, EMA, ICH and other authorities) while driving continuous improvement across clinical, safety/pharmacovigilance, and nonclinical development. You will partner closely with R&D, Clinical, Safety, Regulatory, and IT to enable safe, effective, and high-quality therapeutics. In this role, a typical day might include the following: 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. What youll do: 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. This role might be for you if you: Inspire teams and build followership through clear vision, coaching, and recognition. Are a strategic thinker who can translate regulation and science into pragmatic systems. Thrive in a fast-paced, matrixed environment and can prioritize across complex portfolios. Communicate clearly and influence at all levels, internally and externally. Demonstrate strong analytical skills, sound judgment, and meticulous attention to detail. Are proficient with QMS and quality tools, and comfortable with digital/CSV concepts. What youll bring (Minimum Qualifications): Bachelors degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree (Masters 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 Qualifications: 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. Work Location & Schedule: Primary location: Tarrytown, NY (Hybrid). Occasional travel may be required for inspections, audits, and global site/vendor engagement. Why join us: Opportunity to shape quality excellence across a global development portfolio. Work alongside world-class scientists and developers dedicated to advancing patient outcomes. Competitive compensation and benefits, with career growth in a mission-driven organization. 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 Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons 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) $300,000.00 - $500,000.00

Keywords: Regeneron Pharmaceuticals, Inc., New Britain , Vice President, Global Development Quality, Science, Research & Development , Tarrytown, Connecticut