When & where:
• Location: Warren, NJ (preferred), Armonk or Tarrytown, NY, or Cambridge, MA
• Work model: 4 days/week on-site
• Travel percentage: 20% with some fluctuation expected based on onsite audit/inspection support needs.
Discover your role:
• Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team
• Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response
• Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action
• Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise
• Turn data into direction, reviewing quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership
• Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines
This role requires:
• A Bachelor's degree required; advanced degree preferred with a minimum of 12 years of pharmaceutical industry experience; Healthcare Professional background preferred
• Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)
• Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact
• Proven track record overseeing QMP governance, metrics programs, and cross-functional quality oversight
• Experience managing relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors
• People management experience preferred
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
Salary Range (annually)
$183,100.00 - $305,200.00
