Director, Global Patient Safety-Quality & Compliance

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 135,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness programs within our Global Patient Safety (GPS) organization.

You will collaborate with GPS leadership, Global Development Quality, and the QPPV Office to ensure compliant, high-quality program delivery. This role offers the opportunity to drive data-informed decisions, guide teams through complex regulatory frameworks, and support inspection readiness across

Qualifications

• 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

Responsibilities

• 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

Skills

Quality management

Regulatory knowledge

Leadership

Stakeholder management

Data analysis

Education

Bachelor's degree

Advanced degree

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Our Global Patient Safety (GPS) organization is seeking a Director, GPS Quality & Compliance to support our quality event management and inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality program delivery.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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