Jobs / United States / Regeneron Pharmaceuticals INC
Director, Data Management Process, Quality & Inspection Readiness
Regeneron Pharmaceuticals INC · 🇺🇸 3 Locations
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Regeneron Pharmaceuticals INC paid sponsored hires in similar roles6 certified filings for “Director IT Operations Management” (Computer and Information Systems Managers) in NJ: $220k–$263k, median $236k. Most were filed at wage level II (50%) — 2 lottery entries, ≈31% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Regeneron Pharmaceuticals INC
The US Department of Labor certified 290 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 40 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Regeneron Pharmaceuticals INC →
About the role
Build our future together: The Director, Data Management Process, Quality, and Inspection Readiness provides strategic leadership for Data Management quality, inspection readiness, and process excellence. This role is accountable for establishing and driving standardized approaches to Data Management quality, process frameworks, governance, compliance, and operational execution while ensuring compliance with global regulatory requirements, GCP, and industry best practices. The position serves as the primary Data Management lead for health authority inspections and audits, accountable for inspection preparation, response coordination, functional representation, and ensuring teams are prepared to effectively represent the function during regulatory inspections. In addition, the role also owns and drives the development, governance, and continuous improvement of Data Management processes, training programs, and operational frameworks to support standardized, scalable, compliant, and inspection-ready execution across the Data Management organization. When & where: • Work Location: Warren, NJ, Tarrytown, NY or Armonk, NY • 4 days per week on site • 25% Travel may be required Discover your role: Data Management Quality and Inspection Readiness • Provide strategic leadership for Data Management quality and compliance, ensuring consistent application of quality standards and resolution of complex and systemic issues. • Develop Data Management quality frameworks, including CRO oversight, issue management, escalation pathways, and quality oversight processes to support proactive identification and management of operational quality issues and compliance gaps. • Ensure Data Management quality frameworks and operational activities are aligned with GCP, ICH guidelines, global regulatory requirements, and company quality standards. • Lead quality event and CAPA management activities, including root cause analysis, and implementation of sustainable corrective and preventive actions. Leverage insights to strengthen controls, improve processes, and enhance inspection readiness. • Collaborate with CRO partners and internal stakeholders on quality events, issue escalation, remediation activities, and CAPA implementation. • Lead Data Management inspection readiness and audit support; direct preparation, coordination, and response for health authority inspections. • Lead and conduct independent, risk-based reviews of study documentation and operational conduct at defined and ad hoc timepoints to identify gaps, strengthen compliance, and ensure sustained inspection readiness. • Establish Data Management quality review processes to identify process gaps and deficiencies, training needs, and the documentation of risks, enabling early remediation. • Establish and leverage Data Management KPI & KQI frameworks to provide visibility into performance, data quality, & compliance trends, driving proactive decision-making, continuous improvement, & innovation across the portfolio. • Define, monitor, and perform effectiveness checks measures for Data Management quality, compliance, inspection readiness, training and process performance to drive continuous improvement and operational excellence. • Lead impact assessments for new and evolving regulatory requirements, ensuring appropriate updates to Data Management processes, quality standards, and operational practices. • Educate and guide the Data Management organization on quality standards, regulatory expectations, and inspection readiness practices. • Establish and maintain strong partnerships with Inspection Management and Quality stakeholders to ensure alignment on inspection readiness activities, quality standards, compliance expectations, and remediation strategies. • Oversee Data Man