Director, GPS Quality & Compliance

$183.1k - $305.2k

Regeneron Pharmaceuticals, Inc.

Warren, MI

Responsibilities

Lead functional workstreams in quality event management and inspection readiness programs
Serve as primary contact during GCP and GVP audits, guiding preparation and response
Maintain inspection readiness materials and translate regulatory requirements into operational guidance
Review quality metrics and trend analyses to inform leadership recommendations
Coordinate across teams and functions to drive accountability and continuous improvement

Requirements

Bachelor's degree required; advanced degree preferred
Minimum 12 years pharmaceutical industry experience
Deep knowledge of global PV regulations, FDA CFR, and GVP modules
Demonstrated experience facilitating FDA and EMA/MHRA inspections as point of contact
Proven track record overseeing QMP governance and cross-functional quality oversight
Experience managing relationships across quality, regulatory, and vendor functions
People management experience preferred

Compensation: $183,100-$305,200 annually

Apply

Vacancy posted 6 days ago

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