Director, GPS Quality & Compliance — Inspection Readiness

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

Job summary

Regeneron is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness initiatives. The role collaborates with GPS leadership, Global Development Quality, and the QPPV Office to ensure timely, high-quality program delivery.

Based in Warren, NJ (preferred) with 4 days on-site work and ~20% travel, the position governs GCP/GVP audits and inspections, driving data-driven decisions and tight regulatory alignment across DGQ and vendor relationships.

Qualifications

• This role requires deep knowledge of global PV regulations and inspection readiness.
• Experience facilitating FDA/EMA inspections and serving as an inspection point of contact.
• Strong governance, metrics programs, and cross-functional quality oversight.

Responsibilities

• Lead quality event management and inspection program workstreams.
• Serve as a trusted point of contact during audits, guiding teams through preparation and responses.
• Maintain inspection readiness materials and translate regulatory frameworks into action.
• Champion accountability and continuous improvement across teams.
• Review quality metrics to provide actionable leadership recommendations.
• Present governance topics and quality insights to senior leaders.
• Coordinate across teams and functions, influencing without formal reporting lines.

Skills

Quality event management

Inspection readiness

Audit leadership

Regulatory knowledge

Cross-functional leadership

Education

Bachelor's degree

Advanced degree

Tools

GxP systems

FDA CFR knowledge

Job description

Regeneron is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness initiatives. The role collaborates with GPS leadership, Global Development Quality, and the QPPV Office to ensure timely, high-quality program delivery.

Based in Warren, NJ (preferred) with 4 days on-site work and ~20% travel, the position governs GCP/GVP audits and inspections, driving data-driven decisions and tight regulatory alignment across DGQ and vendor relationships.