Global Patient Safety: Quality & Compliance Director

BioSpace; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron in the United States is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness across the GPS program, partnering with senior leaders to deliver high-quality outcomes.

The role requires leading cross-functional teams, guiding FDA/EMA inspections (GCP/GVP), and turning complex regulatory requirements into practical actions while advancing a culture of accountability, data-driven decisions, and continuous improvement.

Qualifications

• Bachelor's degree required; advanced degree 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.

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 inspections

Leadership

Cross-functional collaboration

Data analysis

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron in the United States is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness across the GPS program, partnering with senior leaders to deliver high-quality outcomes.

The role requires leading cross-functional teams, guiding FDA/EMA inspections (GCP/GVP), and turning complex regulatory requirements into practical actions while advancing a culture of accountability, data-driven decisions, and continuous improvement.