Vice President, Global Development Quality

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 you’ll 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.

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